Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

United States
Code 25jun47

(References in [] brackets are to title 7, United States Code.)
(Act of June 25, 1947; Chapter 125)

Sec. 2. [136] Definitions
For purposes of this Act--
(a) Active Ingredient--The term "active ingredient" means--
(1) in the case of a pesticide other than a plant regulator,
defoliant, or desiccant, or nitrogen stabilizer, an ingredient which
will prevent, destroy, repel, or mitigate any pest;
(2) in the case of a plant regulator, an ingredient which,
through physiological action, will accelerate or retard the rate of
growth or rate of maturation or otherwise alter the behavior of
ornamental or crop plants or the product thereof;
(3) in the case of a defoliant, an ingredient which will cause
the leaves or foliage to drop from a plant;
(4) in the case of a desiccant, an ingredient which will
artificially accelerate the drying of plant tissue; and
(5) in the case of a nitrogen stabilizer, an ingredient which will
prevent or hinder the process of nitrification, denitrification,
ammonia volatilization, or urease production through action affecting
soil bacteria.
(b) Administrator.--The term "Administrator" means the Administrator of the
Environmental Protection Agency.
(c) Adulterated.--The term "adulterated" applies to any pesticide if--
(1) its strength or purity falls below the professed standard of
quality as expressed on its labeling under which it is sold;
(2) any substance has been substituted wholly or in part for the
pesticide; or
(3) any valuable constituent of the pesticide has been wholly or
in part abstracted.
(d) Animal.--The term "animal" means all vertebrate and invertebrate species,
including but not limited to man and other mammals, birds, fish, and
shellfish.
(e) Certified applicator, etc.--
(1) Certified Applicator.-- The term "certified applicator" means
any individual who is certified under section 11 as authorized to use or
supervise the use of any pesticide which is classified for restricted use.
Any applicator who holds or applies registered pesticides, or uses
dilutions of registered pesticides consistent with subsection (ee) of this
section, only to provide a service of controlling pests without delivering
any unapplied pesticide to any person so served is not deemed to be a seller
or distributor of pesticides under this Act.
(2) Private Applicator.--The term "private applicator" means a
certified applicator who uses or supervises the use of any pesticide
which is classified for restricted use for purposes of producing any
agricultural commodity on property owned or rented by the applicator or
the applicator's employer or (if applied without compensation other than
trading of personal services between producers of agricultural commodities)
on the property of another person.
(3) Commercial Applicator.--The term "commercial applicator" means an
applicator (whether or not the applicator is a private applicator with respect
to some uses) who uses or supervises the use of any pesticide which is
classified for restricted use for any purpose or on any property other than as
provided by paragraph (2).
(4) Under the Direct Supervision of a Certified Applicator.--Unless otherwise
prescribed by its labeling, a pesticide shall be considered to be applied under
the direct supervision of a certified applicator if it is applied by a competent
person acting under the instructions and control of a certified applicator who is
available if and when needed, even though such certified applicator is not
physically present at the time and place the pesticide is applied.
(f) Defoliant.--The term "defoliant" means any substance or mixture of substances
intended for causing the leaves or foliage to drop from a plant, with or
without causing abscission.
(g) Desiccant.--The term "desiccant" means any substance or mixture of substances
intended for artificially accelerating the drying of plant tissue.
(h) Device.--The term "device" means any instrument or contrivance (other than
a firearm) which is intended for trapping, destroying, repelling, or
mitigating any pest or any other form of plant or animal life (other
than man and other than bacteria, virus, or other microorganism on or in
living man or other living animals); but not including equipment used
for the application of pesticides when sold separately therefrom.
(i) District court.--The term "district court" means a United States district court,
the District Court of Guam, the District Court of the Virgin Islands,
and the highest court of American Samoa.
(j) Environment.--The term "environment" includes water, air, land, and all plants
and man and other animals living therein, and the interrelationships
which exist among these.
(k) Fungus.--The term "fungus" means any non-chlorophyll-bearing thallophyte
(that is, any non-chlorophyll-bearing plant of a lower order than mosses
and liverworts), as for example, rust, smut, mildew, mold, yeast, and
bacteria, except those on or in living man or other animals and those on
or in processed food, beverages, or pharmaceuticals.
(l) Imminent hazard.--The term "imminent hazard" means a situation which exists when the
continued use of a pesticide during the time required for cancellation
proceeding would be likely to result in unreasonable adverse effects on
the environment or will involve unreasonable hazard to the survival of a
species declared endangered or threatened by the Secretary of the Interior
under Public Law 91-135.
(m) Inert ingredient.--The term "inert ingredient" means an ingredient which is not
active.
(n) Ingredient statement.--The term "ingredient statement" means a statement which
contains--
(1) the name and percentage of each active ingredient, and the
total percentage of all inert ingredients, in the pesticide; and
(2) if the pesticide contains arsenic in any form, a statement
of the percentages of total and water soluble arsenic, calculated as
elementary arsenic.
(o) Insect.--The term "insect" means any of the numerous small invertebrate
animals generally having the body more or less obviously segmented, for
the most part belonging to the class insecta, comprising six-legged,
usually winged forms, as for example, beetles, bugs, bees, flies, and to
other allied classes of arthropods whose members are wingless and
usually have more than six legs, as for example, spiders, mites, ticks,
centipedes, and wood lice.
(p) Label and labeling.--
(1) Label.--The term "label" means the written, printed, or graphic matter
on, or attached to, the pesticide or device or any of its containers
or wrappers.
(2) Labeling.--The term "labeling" means all labels and all other written,
printed, or graphic matter--
(A) accompanying the pesticide or device at any time; or
(B) to which reference is made on the label or in literature
accompanying the pesticide or device, except to current official
publications of the Environmental Protection Agency, the United
States Departments of Agriculture and Interior, the Department
of Health and Human Services, State experiment stations, State
agricultural colleges, and other similar Federal or State
institutions or agencies authorized by law to conduct research
in the field of pesticides.
(q) Misbranded.--
(1) A pesticide is misbranded if--
(A) its labeling bears any statement, design, or graphic
representation relative thereto or to its ingredients which is
false or misleading in any particular;
(B) it is contained in a package or other container or
wrapping which does not conform to the standards established by
the Administrator pursuant to section 25(c)(3);
(C) it is an imitation of, or is offered for sale under the
name of, another pesticide;
(D) its label does not bear the registration number assigned
under section 7 to each establishment in which it was produced;
(E) any word, statement, or other information required by or
under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) and in such terms as
to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use;
(F) the labeling accompanying it does not contain directions
for use which are necessary for effecting the purpose for which
the product is intended and if complied with, together with any
requirements imposed under section 3(d) of this Act, are
adequate to protect health and the environment;
(G) the label does not contain a warning or caution
statement which may be necessary and if complied with, together
with any requirements imposed under section 3(d) of this
Act, is adequate to protect health and the environment; or
(H) in the case of a pesticide not registered in accordance
with section 3 of this Act and intended for export, the
label does not contain, in words prominently placed thereon with
such conspicuousness (as compared with other words, statements,
designs, or graphic matter in the labeling) as to render it
likely to be noted by the ordinary individual under customary
conditions of purchase and use, the following: "Not Registered
for Use in the United States of America".
(2) A pesticide is misbranded if--
(A) the label does not bear an ingredient statement on that
part of the immediate container (and on the outside container or
wrapper of the retail package, if there be one, through which
the ingredient statement on the immediate container cannot be
clearly read) which is presented or displayed under customary
conditions of purchase, except that a pesticide is not
misbranded under this subparagraph if--
(i) The size or form of the immediate container, or the
outside container or wrapper of the retail package, makes it
impracticable to place the ingredient statement on the part
which is presented or displayed under customary conditions
of purchase; and
(ii) the ingredient statement appears prominently on
another part of the immediate container, or outside
container or wrapper, permitted by the Administrator;
(B) the labeling does not contain a statement of the use
classification under which the product is registered;
(C) there is not affixed to its container, and to the
outside container or wrapper of the retail package, if there be
one, through which the required information on the immediate
container cannot be clearly read, a label bearing--
(i) the name and address of the producer, registrant, or
person for whom produced;
(ii) the name, brand, or trademark under which the
pesticide is sold;
(iii) the net weight or measure of the content, except
that the Administrator may permit reasonable variations; and
(iv) when required by regulation of the Administrator to
effectuate the purposes of this Act, the registration
number assigned to the pesticide under this Act, and
the use classification; and
(D) the pesticide contains any substance or substances in
quantities highly toxic to man, unless the label shall bear, in
addition to any other matter required by this Act--
(i) the skull and crossbones;
(ii) the word "poison" prominently in red on a
background of distinctly contrasting color; and
(iii) a statement of a practical treatment (first aid or
otherwise) in case of poisoning by the pesticide.
(r) Nematode.--The term "nematode" means invertebrate animals of the phylum
nemathelminthes and class nematoda, that is, unsegmented round worms
with elongated, fusiform, or saclike bodies covered with cuticle, and
inhabiting soil, water, plants, or plant parts; may also be called nemas
or eelworms.
(s) Person.--The term "person" means any individual, partnership, association,
corporation, or any organized group of persons whether incorporated or
not.
(t) Pest.--The term "pest" means (1) any insect, rodent, nematode, fungus,
weed, or (2) any other form of terrestrial or aquatic plant or animal
life or virus, bacteria, or other micro-organism (except viruses,
bacteria, or other micro-organisms on or in living man or other living
animals) which the Administrator declares to be a pest under section
25(c)(1).
(u) Pesticide.--The term "pesticide" means (1) any substance or mixture of
substances intended for preventing, destroying, repelling, or mitigating
any pest, (2) any substance or mixture of substances intended for
use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen
stabilizer, except that the term "pesticide" shall not include any article
that is a "new animal drug" within the meaning of section 201(w) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(w)) that has been determined by the
Secretary of Health and Human Services not to be a new animal drug by a
regulation establishing conditions of use for the article, or that is an animal
feed within the meaning of section 201(x) of such Act (21 U.S.C. 321(x)) bearing
or containing a new animal drug. The term "pesticide" does not include liquid
chemical sterilant products (including any sterilant or subordinate disinfectant
claims on such products) for use on a critical or semi-critical device, as
defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
For purposes of the preceding sentence, the term "critical device" includes any
device which is introduced directly into the human body, either into or in
contact with the bloodstream or normally sterile areas of the body and the term
"semi-critical device" includes any device which contacts intact mucous membranes
but which does not ordinarily penetrate the blood barrier or otherwise enter
normally sterile areas of the body.
(v) Plant regulator.--The term "plant regulator" means any substance or
mixture of substances intended, through physiological action, for accelerating
or retarding the rate of growth or rate of maturation, or for otherwise
altering the behavior of plants or the produce thereof, but shall not
include substances to the extent that they are intended as plant
nutrients, trace elements, nutritional chemicals, plant inoculants, and
soil amendments. Also, the term "plant regulator" shall not be
required to include any of such of those nutrient mixtures or soil
amendments as are commonly known as vitamin-hormone horticultural
products, intended for improvement, maintenance, survival, health, and
propagation of plants, and as are not for pest destruction and are
nontoxic, nonpoisonous in the undiluted packaged concentration.
(w) Producer and produce.--The term "producer" means the person who manufactures,
prepares, compounds, propagates, or processes any pesticide or device or active
ingredient used in producing a pesticide. The term "produce" means to
manufacture, prepare, compound, propagate, or process any pesticide or
device or active ingredient used in producing a pesticide. The dilution
by individuals of formulated pesticides for their own use and according
to the directions on registered labels shall not of itself result in
such individuals being included in the definition of "producer" for
the purposes of this Act.
(x) Protect health and the environment.--The terms "protect health and the
environment" and "protection of health and the environment" mean protection against
any unreasonable adverse effects on the environment.
(y) Registrant.--The term "registrant" means a person who has registered any
pesticide pursuant to the provisions of this Act.
(z) Registration.--The term "registration" includes reregistration.
(aa) State.--The term "State" means a State, the District of Columbia, the
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust
Territory of the Pacific Islands, and American Samoa.
(bb) Unreasonable Adverse Effects on the Environment.--The term "unreasonable
adverse effects on the environment" means (1) any unreasonable risk to man or the
environment, taking into account the economic, social, and environmental costs
and benefits of the use of any pesticide, or (2) a human dietary risk from
residues that result from a use of a pesticide in or on any food inconsistent
with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 346a)./1/ The Administrator shall consider the risks and benefits of
public health pesticides separate from the risks and benefits of other pesticides.
In weighing any regulatory action concerning a public health pesticide under this
Act, the Administrator shall weigh any risks of the pesticide against the health
risks such as diseases transmitted by the vector to be controlled by the
pesticide.
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/1/ Sec. 304 of P.L. 104-170 amended sec.2 (bb) (7 U.S.C. 136(bb)) by inserting
"1" and ", or (2)" and all that follows through "346a).", without sepcifying the Act that
was being amended. The amendments were executed to this Act to effectuate the probable
intent of Congress.
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(cc) Weed.--The term "weed" means any plant which grows where not wanted.
(dd) Establishment.--The term "establishment" means any place where a pesticide
or device or active ingredient used in producing a pesticide is produced,
or held, for distribution or sale.
(ee) To Use Any Registered Pesticide in a Manner Inconsistent with Its
Labeling.--The term "to use any registered pesticide in a manner inconsistent
with its labeling" means to use any registered pesticide in a manner
not permitted by the labeling, except that the term shall not include
(1) applying a pesticide at any dosage, concentration, or frequency less
than that specified on the labeling unless the labeling specifically
prohibits deviation from the specified dosage, concentration, or
frequency, (2) applying a pesticide against any target pest not
specified on the labeling if the application is to the crop, animal, or
site specified on the labeling, unless the Administrator has required
that the labeling specifically state that the pesticide may be used only
for the pests specified on the labeling after the Administrator has
determined that the use of the pesticide against other pests would cause
an unreasonable adverse effect on the environment, (3) employing any
method of application not prohibited by the labeling unless the labeling
specifically states that the product may be applied only by the methods
specified on the labeling, (4) mixing a pesticide or pesticides with a
fertilizer when such mixture is not prohibited by the labeling, (5) any
use of a pesticide in conformance with section 5, 18, or 24 of
this Act, or (6) any use of a pesticide in a manner that the
Administrator determines to be consistent with the purposes of this
Act. After March 31, 1979, the term shall not include the use of
a pesticide for agricultural or forestry purposes at a dilution less
than label dosage unless before or after that date the Administrator
issues a regulation or advisory opinion consistent with the study
provided for in section 27(b) of the Federal Pesticide Act of 1978,
which regulation or advisory opinion specifically requires the use of
definite amounts of dilution.
(ff) Outstanding Data Requirement.--
(1) In General.--The term "outstanding data requirement" means a requirement
for any study, information, or data that is necessary to make a
determination under section 3(c)(5) of this title and which
study, information, or data--
(A) has not been submitted to the Administrator; or
(B) if submitted to the Administrator, the Administrator has
determined must be resubmitted because it is not valid,
complete, or adequate to make a determination under section
3(c)(5) of this title and the regulations and guidelines
issued under such section.
(2) Factors.--In making a determination under paragraph (1)(B) respecting a
study, the Administrator shall examine, at a minimum, relevant
protocols, documentation of the conduct and analysis of the study,
and the results of the study to determine whether the study and the
results of the study fulfill the data requirement for which the
study was submitted to the Administrator.
(gg) To Distribute or Sell.--The term "to distribute or sell" means to distribute,
sell, offer for sale, hold for distribution, hold for sale, hold for shipment, ship,
deliver for shipment, release for shipment, or receive and (having so
received) deliver or offer to deliver. The term does not include the
holding or application of registered pesticides or use dilutions thereof
by any applicator who provides a service of controlling pests without
delivering any unapplied pesticide to any person so served.
(hh)Nitrogen Stabilizer.--The term "nitrogen stabilizer" means any substance or mixture
of substances intended for preventing or hindering the process of nitrification,
denitrification, ammonia volatilization, or urease production through action upon
soil bacteria. Such term shall not include--
(1) dicyandiamide;
(2) ammonium thiosulfate; or
(3) any substance or mixture of substances.--
(A) that was not registered pursuant to section 3 prior to January 1, 1992; and
(B) that was in commercial agronomic use prior to January 1, 1992, with respect
to which after January 1, 1992, the distributor or seller of the substance or
mixture has made no specific claim of prevention or hindering of the process of
nitrification, denitrification, ammonia volatilization urease production regardless
of the actual use of purpose for, or future use or purpose for, the substance or
mixture.
Statements made in materials required to be submitted to any State legislative or
regulatory authority, or required by such authority to be included in the labeling
or other literature accompanying any such substance or mixture shall not be deemed
a specific claim within the meaning of this subsection.
(jj) /1/ Maintenance Applicator.--The term "maintenance
applicator" means any individual who, in the principal course of such individual's
employment, uses, or supervises the use of, a pesticide not classified for restricted
use (other than a ready to use consumer products pesticide); for the purpose of providing
structural pest control or lawn pest control including janitors, general maintenance
personnel, sanitation personnel, and grounds maintenance personnel. The term
"maintenance applicator" does not include private applicators as defined in section
2(e)(2); individuals who use antimicrobial pesticides, sanitizers or disinfectants;
individuals employed by Federal, State, and local governments or any political
subdivisions thereof, or individuals who use pesticides not classified for
restricted use in or around their homes, boats, sod farms, nurseries, greenhouses,
or other commercial property.
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/1/ So in original (as added by sec. 120 of P.L. 104-70). This subsection
should probably be "(ii)" and subsequent subsections should be redesignated accordingly.
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(kk) Service Technician.--The term "service technician" means any individual who
uses or supervises the use of pesticides (other than a ready to use consumer
products pesticide) for the purpose of providing structural pest control or lawn
pest control on the property of another for a fee. The term "service technician"
does not include individuals who use antimicrobial pesticides, sanitizers or
disinfectants; or who otherwise apply ready to use consumer products pesticides.
(ll) Minor Use.--The term "minor use" means the use of a pesticide on an animal,
on a commercial agricultural crop or site, or for the protection of public health
where--
(1) the total United States acreage for the crop is less than 300,000 acres,
as determined by the Secretary of Agriculture; or
(2)the Administrator, in consultation with the Secretary of Agriculture,
determines that, based on information provided by an applicant for
registration or a registrant, the use does not provide sufficient economic
incentive to support the initial registration or continuing registration or
a pesticide for such use and--
(A) there are insufficient efficacious alternative registered pesticides
available for the use;
(B) the alternatives to the pesticide use pose greater risks to the
environment or human health;
(C) the minor use pesticide plays or will play a significant part in
managing pest resistance; or
(D) the minor use pesticide plays or will play a significant part in
an integrated pest management program.
The status as a minor use under this subsection shall continue as long as the
Administrator has not determined that, based on existing data, such use may cause
an unreasonable adverse effect on the environment and the use otherwise qualifies
for such status.
(mm) Antimicrobial Pesticide.--
(1) In General.--The term "antimicrobial pesticide" means a pesticide that--
(A) is intended to--
(i) disinfect, sanitize, reduce, or mitigate growth or development of
microbiological organisms; or
(ii) protect inanimate objects, industrial processes or systems, surfaces,
water, or other chemical substances from contamination, fouling, or
deterioration caused by bacteria, viruses, fungi, protozoa, algae, or
slime; and
(B) in the intended use is exempt from, or otherwise not subject to, a tolerance
under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
346a and 348) or a food additive regulation under section 409 of such Act.
(2) Excluded Products.--The term "antimicrobial pesticide" does not include--
(A) a wood preservative or antifouling paint product for which a claim of
pesticidal activity other than or in addition to an activity described in
paragraph (1) is made;
(B) an agricultural fungicide product; or
(C) an aquatic herbicide product.
(3) Included Products.--The term "antimicrobial pesticide" does include any other
chemical sterilant product (other that liquid chemical sterilant products exempt
under subsection (u)), any other disinfectant product, any other industrial
microbiocide product, and any other preservative product that is not excluded
by paragraph (2).
(nn) Public Health Pesticide.--The term "public health pesticide" means any minor use
pesticide product registered for use and used predominantly in public health programs
for vector control or for other recognized health protection uses, including the
prevention or mitigation of viruses, bacteria, or other microorganisms (other than
viruses, bacteria, or other microorganisms on or in living man or other living
animal) that pose a threat to public health.
(oo) Vector.--The term "vector" means any organism capable of transmitting the
causative agent of human disease or capable of producing human discomfort or
injury, including mosquitoes,, flies, fleas, cockroaches, or other insects and
ticks, mites, or rats.
Sec. 3 [136a] Registration of pesticides.
(a) Requirement of Registration.--Except as provided by this Act, no
person in any State may distribute or sell to any person any pesticide that is
not registered under this Act. To the extent necessary to prevent
unreasonable adverse effects on the environment, the Administrator may by
regulation limit the distribution, sale, or use in any State of any pesticide
that is not registered under this Act and that is not the subject of
an experimental use permit under section 5 of this title or an
emergency exemption under section 18 of this title.
(b) Exemptions.--A pesticide which is not registered with the Administrator may be
transferred if--
(1) the transfer is from one registered establishment to another
registered establishment operated by the same producer solely for
packaging at the second establishment or for use as a constituent
part of another pesticide produced at the second establishment; or
(2) the transfer is pursuant to and in accordance with the
requirements of an experimental use permit.
(c) Procedure for Registration.--
(1) Statement Required.--Each applicant for registration of a pesticide shall
file with the Administrator a statement which includes--
(A) the name and address of the applicant and of any other
person whose name will appear on the labeling;
(B) the name of the pesticide;
(C) a complete copy of the labeling of the pesticide, a
statement of all claims to be made for it, and any directions
for its use;
(D) the complete formula of the pesticide;
(E) a request that the pesticide be classified for general
use or for restricted use, or for both; and
(F) except as otherwise provided in paragraph (2)(D), if
requested by the Administrator, a full description of the tests
made and the results thereof upon which the claims are based, or
alternatively a citation to data that appear in the public
literature or that previously had been submitted to the
Administrator and that the Administrator may consider in
accordance with the following provisions:
(i) With respect to pesticides containing active
ingredients that are initially registered under this
Act after the date of enactment of the Federal Pesticide Act of
1978, data submitted to support the application for the original
registration of the pesticide, or an application for an amendment
adding any new use to the registration and that pertains solely to
such new use, shall not, without the written permission of the
original data submitter, be considered by the Administrator
to support an application by another person during a period
of ten years following the date the Administrator first
registers the pesticide, except that such permission shall
not be required in the case of defensive data.
(ii) The period of exclusive data use provided under clause (i)
shall be extended 1 additional year for each minor uses registered
after the date of enactment of this clause and within 7 years of
the commencement of the exclusive use period, up to a total of 3
additional years for all minor uses registered by the Administrator
if the Administrator, in consultation with the Secretary of
Agriculture, determines that, based on information provided by an
applicant for registration or a registrant, that--
(I) there are insufficient efficacious alternative registered
pesticides available for the use;
(II) the alternatives to the minor use pesticide pose greater
risks to the environment or human health;
(III) the minor use pesticide plays or will play a significant
part in managing pest resistance; or
(IV) the minor use pesticide plays or will play a significant
part in an integrated pest management program.
The registration of a pesticide for a minor use on a crop grouping
established by the Administrator shall be considered for purposes of
this clause 1 minor use for each representative crop for which data are
provided in the crop grouping. Any additional exclusive use period
under this clause shall be modified as appropriate or terminated if the
registrant voluntarily cancels the product or deletes from the
registration the minor uses which formed the basis for the extension of
the additional exclusive use period or if the Administrator determines
that the registrant is not actually marketing the product for such minor
uses.
(iii) Except as otherwise provided in clause (i), with
respect to data submitted after December 31, 1969, by an
applicant or registrant to support an application for
registration, experimental use permit, or amendment adding a
new use to an existing registration, to support or maintain
in effect an existing registration, or for reregistration,
the Administrator may, without the permission of the
original data submitter, consider any such item of data in
support of an application by any other person (hereinafter
in this subparagraph referred to as the "applicant")
within the fifteen-year period following the date the data
were originally submitted only if the applicant has made an
offer to compensate the original data submitter and
submitted such offer to the Administrator accompanied by
evidence of delivery to the original data submitter of the
offer. The terms and amount of compensation may be fixed by
agreement between the original data submitter and the
applicant, or, failing such agreement, binding arbitration
under this subparagraph. If, at the end of ninety days after
the date of delivery to the original data submitter of the
offer to compensate, the original data submitter and the
applicant have neither agreed on the amount and terms of
compensation nor on a procedure for reaching an agreement on
the amount and terms of compensation, either person may
initiate binding arbitration proceedings by requesting the
Federal Mediation and Conciliation Service to appoint an
arbitrator from the roster of arbitrators maintained by such
Service. The procedure and rules of the Service shall be
applicable to the selection of such arbitrator and to such
arbitration proceedings, and the findings and determination
of the arbitrator shall be final and conclusive, and no
official or court of the United States shall have power or
jurisdiction to review any such findings and determination,
except for fraud, misrepresentation, or other misconduct by
one of the parties to the arbitration or the arbitrator
where there is a verified complaint with supporting
affidavits attesting to specific instances of such fraud,
misrepresentation, or other misconduct. The parties to the
arbitration shall share equally in the payment of the fee
and expenses of the arbitrator. If the Administrator
determines that an original data submitter has failed to
participate in a procedure for reaching an agreement or in
an arbitration proceeding as required by this subparagraph,
or failed to comply with the terms of an agreement or
arbitration decision concerning compensation under this
subparagraph, the original data submitter shall forfeit the
right to compensation for the use of the data in support of
the application. Notwithstanding any other provision of this
Act, if the Administrator determines that an
applicant has failed to participate in a procedure for
reaching an agreement or in an arbitration proceeding as
required by this subparagraph, or failed to comply with the
terms of an agreement or arbitration decision concerning
compensation under this subparagraph, the Administrator
shall deny the application or cancel the registration of the
pesticide in support of which the data were used without
further hearing. Before the Administrator takes action under
either of the preceding two sentences, the Administrator
shall furnish to the affected person, by certified mail,
notice of intent to take action and allow fifteen days from
the date of delivery of the notice for the affected person
to respond. If a registration is denied or canceled under
this subparagraph, the Administrator may make such order as
the Administrator deems appropriate concerning the continued
sale and use of existing stocks of such pesticide.
Registration action by the Administrator shall not be
delayed pending the fixing of compensation.
(iv) After expiration of any period of exclusive use
and any period for which compensation is required for the
use of an item of data under clauses (i), (ii), and (iii), the
Administrator may consider such item of data in support of
an application by any other applicant without the permission
of the original data submitter and without an offer having
been received to compensate the original data submitter for
the use of such item of data.
(v) The period of exclusive use provided under clause (ii)
shall not take effect until 1 year after enactment of this clause,
except where an applicant or registrant is applying for the
registration is applying for the registration of a pesticide
containing an active ingredient not previously registered.
(vi) With respect to data submitted after the date of
enactment of this clause by an applicant or registrant to support
an amendment adding a new use to an existing registration that does
not retain any period of exclusive use, if such data relates solely
to a minor use of a pesticide, such data shall not, without the
written permission of the original data submitter, be considered
by the Administrator to support an application for a minor use by
another person during the period of 10 years following the date of
submission of such data. The applicant or registrant at the time the
new minor use is requested shall notify the Administrator that to
the best of their knowledge the exclusive use period for the pesticide
has expired and that the data pertaining solely to the minor use of
a pesticide is eligible for the provisions of this paragraph. If the
minor use registration which is supported by data submitted pursuant
to this subsection is voluntarily canceled or if such data are
subsequently used to support a nonminor use, the data shall no longer
be subject to the exclusive use provisions of this clause but shall
instead be considered by the Administrator in accordance with the
provisions of clause (i), as appropriate.
(G) If the applicant is requesting that the registration or amendment to
the registration of a pesticide be expedited, an explanation of the basis for
for the request must be submitted, in accordance with paragraph (10) of this
subsection.
(2) Data in Support of Registration.--
(A) In General.-- The Administrator shall publish guidelines specifying
the kinds of information which will be required to support the
registration of a pesticide and shall revise such guidelines from
time to time. If thereafter the Administrator requires any
additional kind of information under subparagraph (B) of this
paragraph, the Administrator shall permit sufficient time for
applicants to obtain such additional information. The Administrator,
in establishing standards for data requirements for the registration
of pesticides with respect to minor uses, shall make such standards
commensurate with the anticipated extent of use, pattern of use, the
public health and agricultural need for such minor use, and the level
and degree of potential beneficial or adverse effects on man and the environment.
The Administrator shall not require a person to submit, in
relation to a registration or reregistration of a pesticide for
minor agricultural use under this Act, any field residue data
from a geographic area where the pesticide will not be registered for such
use. In the development of these standards, the Administrator shall
consider the economic factors of potential national volume of use, extent
of distribution, and the impact of the cost of meeting the requirements
on the incentives for any potential registrant to undertake the development
of the required data. Except as provided by section 10, within 30 days after
the Administrator registers a pesticide under this Act the Administrator
shall make available to the public the data called for in the registration
statement together with such other scientific information as the Administrator
deems relevant to the Administrator's decision.
(B) Additional Data.--(i) If the Administrator determines that additional
data are required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing registrants
of the pesticide to which the determination relates and provide a
list of such registrants to any interested person.
(ii) Each registrant of such pesticide shall provide evidence
within ninety days after receipt of notification that it is taking
appropriate steps to secure the additional data that are required.
Two or more registrants may agree to develop jointly, or to share in
the cost of developing, such data if they agree and advise the
Administrator of their intent within ninety days after notification.
Any registrant who agrees to share in the cost of producing the data
shall be entitled to examine and rely upon such data in support of
maintenance of such registration. The Administrator shall issue a
notice of intent to suspend the registration of a pesticide in
accordance with the procedures prescribed by clause (iv) if a
registrant fails to comply with this clause.
(iii) If, at the end of sixty days after advising the
Administrator of their agreement to develop jointly, or share in the
cost of developing, data, the registrants have not further agreed on
the terms of the data development arrangement or on a procedure for
reaching such agreement, any of such registrants may initiate
binding arbitration proceedings by requesting the Federal Mediation
and Conciliation Service to appoint an arbitrator from the roster of
arbitrators maintained by such Service. The procedure and rules of
the Service shall be applicable to the selection of such arbitrator
and to such arbitration proceedings, and the findings and
determination of the arbitrator shall be final and conclusive, and
no official or court of the United States shall have power or
jurisdiction to review any such findings and determination, except
for fraud, misrepresentation, or other misconduct by one of the
parties to the arbitration or the arbitrator where there is a
verified complaint with supporting affidavits attesting to specific
instances of such fraud, misrepresentation, or other misconduct. All
parties to the arbitration shall share equally in the payment of the
fee and expenses of the arbitrator. The Administrator shall issue a
notice of intent to suspend the registration of a pesticide in
accordance with the procedures prescribed by clause (iv) if a
registrant fails to comply with this clause.
(iv) Notwithstanding any other provision of this Act, if
the Administrator determines that a registrant, within the time
required by the Administrator, has failed to take appropriate steps
to secure the data required under this subparagraph, to participate
in a procedure for reaching agreement concerning a joint data
development arrangement under this subparagraph or in an arbitration
proceeding as required by this subparagraph, or to comply with the
terms of an agreement or arbitration decision concerning a joint
data development arrangement under this subparagraph, the
Administrator may issue a notice of intent to suspend such
registrant's registration of the pesticide for which additional data
is required. The Administrator may include in the notice of intent
to suspend such provisions as the Administrator deems appropriate
concerning the continued sale and use of existing stocks of such
pesticide. Any suspension proposed under this subparagraph shall
become final and effective at the end of thirty days from receipt by
the registrant of the notice of intent to suspend, unless during
that time a request for hearing is made by a person adversely
affected by the notice or the registrant has satisfied the
Administrator that the registrant has complied fully with the
requirements that served as a basis for the notice of intent to
suspend. If a hearing is requested, a hearing shall be conducted
under section 6(d) of this Act. The only matters for resolution
at that hearing shall be whether the registrant has failed to take
the action that served as the basis for the notice of intent to
suspend the registration of the pesticide for which additional data
is required, and whether the Administrator's determination with
respect to the disposition of existing stocks is consistent with
this Act. If a hearing is held, a decision after completion
of such hearing shall be final. Notwithstanding any other provision
of this Act, a hearing shall be held and a determination made
within seventy-five days after receipt of a request for such
hearing. Any registration suspended under this subparagraph shall be
reinstated by the Administrator if the Administrator determines that
the registrant has complied fully with the requirements that served
as a basis for the suspension of the registration.
(v) Any data submitted under this subparagraph shall be subject
to the provisions of paragraph (1)(D). Whenever such data are
submitted jointly by two or more registrants, an agent shall be
agreed on at the time of the joint submission to handle any
subsequent data compensation matters for the joint submitters of
such data.
(vi) Upon request of a registrant the Administrator shall, in the
case of a minor use, extend the deadline for the production of residue
chemistry data under this subparagraph for data required solely to
support that minor use until the final deadline for submission of data
under section 4 for the other uses of the pesticide established as of
the date of enactment of the Food Quality Protection Act of 1996, if--
(I) the data to support other uses of the pesticide on a food are
being provided;
(II) the registrant, in submitting a request for such an extension,
provides a schedule, including interim dates to measure progress, to
assure that the data production will be completed before the expiration
of the extension period;
(III) the Administrator has determined that such extension will not
significantly delay the Administrator's schedule for issuing a
reregistration eligibility determination required under section 4; and
(IV) the Administrator has determined that based on existing data, such
extension would not significantly increase the risk of any unreasonable
adverse effect on the environment./1/ If the Administrator grants an
extension under this clause, the Administrator shall monitor the
development of the data and shall ensure that the registrant is meeting
the schedule for the production of the data. If the Administrator
determines that the registrant is not meeting or has not met the schedule
for the production of such data, the Administrator may proceed in
accordance with clause (iv) regarding the continued registration of the
affected products with the minor use and shall inform the public of such
action. Notwithstanding the provisions of this clause, the Administrator
may take action to modify or revoke the extension under this clause if the
Administrator determines that the extension for the minor use may cause
an unreasonable adverse effect on the environment. In such circumstance,
the Administrator shall provide, in writing to the registrant, a notice
revoking the extension of time for submission of data. Such data shall
instead be due in accordance with the date established by the Administrator
for the submission of the data.
-----------------------------------------------------------------------------------------
/1/ Indentation of the following sentences of this clause is so in the original
(as added by sec. 201(c)(1) of P.L. 104-170). Probably should be indented the same as
flush matter of this clause.
-----------------------------------------------------------------------------------------
(vii) If the registrant does not commit to support a specific minor use of the
pesticide, but is supporting and providing data in a timely and adequate fashion
to support uses of the pesticide on a food, or if all uses of the pesticide are
nonfood uses and the registrant does not commit to support a specific minor use
of the pesticide but is supporting and providing data in a timely and adequate
fashion to support other nonfood uses of the pesticide, the Administrator, at the
written request of the registrant, shall not take any action pursuant to this
clause in regard to such unsupported minor use until the final deadline
established as the date of enactment of the Food Quality Protection Act of 1996,
for the submission of data under section 4 for the supported uses identified
pursuant to this clause unless the Administrator determines that the absence of
the data is significant enough to cause human health or environmental concerns. On the
basis of such determination, the Administrator shall publish in the Federal Register
a notice of the receipt of the request and the effective date upon which the uses
not being supported will be voluntarily deleted from the registration pursuant to
section 6(f)(1). If the Administrator grants an extension under this clause, the
Administrator shall monitor the development of the data for the uses being
supported and shall ensure that the registrant is meeting the schedule for the
production of such data. If the Administrator determines that the registrant is
not meeting or has not met the schedule for the production of such data, the
Administrator may proceed in accordance with clause (iv) of this subparagraph
regarding the continued registration of the affected products with the minor
and other uses and shall inform the public of such action in accordance with
section 6(f)(2). Notwithstanding the provisions of this clause, the
Administrator may deny, modify, or revoke the temporary extension under this
subparagraph if the Administrator determines that the continuation of the minor
use may cause an unreasonable adverse effects on the environment. In the event of
modification or revocation, the Administrator shall provide, in writing, to the
registrant a notice revoking the temporary extension and establish a new effective
date by which the minor use shall be deleted from the registration.
(viii)(I) If data required to support registration of a pesticide under
subparagraph (A) is requested by a Federal or State regulatory authority, the
Administrator shall, to the extent practicable, coordinate data requirements,
test protocols, timetables, and standards of review and reduce burdens and
redundancy cause to the registrant by multiple requirements on the registrant.
(II) The Administrator may enter into a cooperative agreement with a State to
carry out subclause (I).
(III) Not later than 1 year after the date of enactment of this clause, the
Administrator shall develop a process to identify and assist in alleviating
future disparities between Federal and State data requirements.
(C) Simplified Procedures.-- Within nine months after the date of enactment
of this subparagraph, the Administrator shall, by regulation, prescribe simplified
procedures for the registration of pesticides, which shall include the
provisions of subparagraph (D) of this paragraph.
(D) Exemption.--No applicant for registration of a pesticide who
proposes to purchase a registered pesticide from another producer in
order to formulate such purchased pesticide into the pesticide that
is the subject of the application shall be required to--
(i) submit or cite data pertaining to such purchased
product; or
(ii) offer to pay reasonable compensation otherwise required
by paragraph (1)(D) of this subsection for the use of any such
data.
(E) Minor Use Waiver.--In handling the registration of a pesticide for a
minor use, the Administrator may waive otherwise applicable data requirements
if the Administrator determines that the absence of such data will not prevent
the Administrator from determining--
(i) the incremental risk presented by the minor use of the pesticide; and
(ii) that such risk, if any, would not be an unreasonable adverse effect
on the environment.
(3) Time for Acting with Respect to Application.--
(A) In General.-- The Administrator shall review the data after receipt of the
application and shall, as expeditiously as possible, either register
the pesticide in accordance with paragraph (5), or notify the
applicant of the Administrator's determination that it does not
comply with the provisions of the Act in accordance with
paragraph (6).
(B) Identical or Substantially Similar.--(i) The Administrator shall, as
expeditiously as possible, review and act on any application received by the
Administrator that--
(I) proposes the initial or amended registration of an end-
use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and labeling
to a currently-registered pesticide identified in the
application, or that would differ in composition and labeling
from such currently-registered pesticide only in ways that would
not significantly increase the risk of unreasonable adverse
effects on the environment; or
(II) proposes an amendment to the registration of a
registered pesticide that does not require scientific review of
data.
(ii) In expediting the review of an application for an action
described in clause (i), the Administrator shall--
(I) within 45 days after receiving the application, notify
the registrant whether or not the application is complete and,
if the application is found to be incomplete, reject the
application;
(II) within 90 days after receiving a complete application,
notify the registrant if the application has been granted or
denied; and
(III) if the application is denied, notify the registrant in
writing of the specific reasons for the denial of the
application.
(C) Minor use registration
(i) The Administrator shall, as expeditiously as possible, review and act on
any complete application--
(I) that proposes the initial registration of a new
pesticide active ingredient if the active ingredient is proposed to be
registered solely for minor uses, or proposes a registration amendment solely
for minor uses to an existing registration; or
(II) for a registration or a registration amendment that proposes significant
minor uses.
(ii) For the purposes of clause (i) -
(I) the term "as expeditiously as possible" means that the Administrator
shall, to the greatest extent practicable, complete a review and evaluation of
all data, submitted with a complete application, within 12 months after the
submission of the complete application, and the failure of the Administrator to
complete such a review and evaluation under clause (i) shall not be subject to
judicial review; and
(II) the term "significant minor uses" means 3 or more minor uses proposed
for every nonminor use, a minor use that would, in the judgment of the
Administrator, serve as a replacement for any use which has been canceled in the
5 years preceding the receipt of the application, or a minor use that in the
opinion of the Administrator would avoid the reissuance of an emergency exemption
under section 18 for that minor use.
(D) Adequate Time for Submission of Minor Use Data.-- If a registrant makes a
request for a minor use waiver, regarding data required by the Administrator, pursuant
to paragraph (2)(E), and if the Administrator denies in whole or in part such data
waiver request, the registrant shall have a full-time period for providing such data.
For purposes of this subparagraph, the term "full-time period" means the time period
originally established by the Administrator for submission of such data, beginning
with the date of receipt by the registrant of the Administrator's notice of denial.
(4) Notice of Application.--The Administrator shall publish in the Federal Register,
promptly after receipt of the statement and other data required pursuant to paragraphs (1)
and (2), a notice of each application for registration of any pesticide if it contains any
new active ingredient or if it would entail a changed use pattern. The notice shall
provide for a period of 30 days in which any Federal agency or any other interested person
may comment.
(5) Approval of Registration.--The Administrator shall register a pesticide if the
Administrator determines that, when considered with any restrictions imposed under
subsection (d)--
(A) its composition is such as to warrant the proposed claims for it;
(B) its labeling and other material required to be submitted comply with the
requirements of this Act;
(C) it will perform its intended function without unreasonable adverse effects on
the environment; and
(D) when used in accordance with widespread and commonly recognized practice it
will not generally cause unreasonable adverse effects on the environment.
The Administrator shall not make any lack of essentiality a
criterion for denying registration of any pesticide. Where two
pesticides meet the requirements of this paragraph, one should not
be registered in preference to the other. In considering an
application for the registration of a pesticide, the Administrator
may waive data requirements pertaining to efficacy, in which event
the Administrator may register the pesticide without determining
that the pesticide's composition is such as to warrant proposed
claims of efficacy. If a pesticide is found to be efficacious by any
State under section 24(c) of this Act, a presumption is
established that the Administrator shall waive data requirements
pertaining to efficacy for use of the pesticide in such State.
(6) Denial of Registration.--If the Administrator determines that the requirements of
paragraph (5) for registration are not satisfied, the Administrator shall notify the
applicant for registration of the Administrator's determination and of the Administrator's
reasons (including the factual basis) therefor, and that, unless the applicant corrects
the conditions and notifies the Administrator thereof during the 30-day period beginning
with the day after the date on which the applicant receives the notice, the Administrator
may refuse to register the pesticide. Whenever the Administrator refuses to register a
pesticide, the Administrator shall notify the applicant of the Administrator's decision
and of the Administrator's reasons (including the factual basis) therefor. The
Administrator shall promptly publish in the Federal Register notice of such denial of
registration and the reasons therefor. Upon such notification, the applicant for
registration or other interested person with the concurrence of the applicant shall have
the same remedies as provided for in section 6.
(7) Registration under Special Circumstances.--Notwithstanding the provisions of
paragraph (5)--
(A) The Administrator may conditionally register or amend the registration of a
pesticide if the Administrator determines that (i) the pesticide and proposed use are
identical or substantially similar to any currently registered pesticide and use
thereof, or differ only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment, (ii) approving the registration or
amendment in the manner proposed by the applicant would not significantly increase the
risk of any unreasonable adverse effect on the environment. An applicant seeking
conditional registration or amended registration under this subparagraph shall submit
such data as would be required to obtain registration of a similar pesticide under
paragraph (5). If the applicant is unable to submit an item of data because it has
not yet been generated, the Administrator may register or amend the registration of
the pesticide under such conditions as will require the submission of such data not
later than the time such data are required to be submitted with respect to similar
pesticides already registered under this Act.
(B) The Administrator may conditionally amend the registration of a pesticide to
permit additional uses of such pesticide notwithstanding that data concerning the
pesticide may be insufficient to support an unconditional amendment, if the
Administrator determines that (i) the applicant has submitted satisfactory data
pertaining to the proposed additional use, and (ii) amending the registration in the
manner proposed by the applicant would not significantly increase the risk of any
unreasonable adverse effect on the environment. Notwithstanding the foregoing
provisions of this subparagraph, no registration of a pesticide may be amended to
permit an additional use of such pesticide if the Administrator has issued a notice
stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria
associated in whole or in part with human dietary exposure enumerated in regulations
issued under this Act, and during the pendency of any risk-benefit evaluation
initiated by such notice, if (I) the additional use of such pesticide involves a major
food or feed crop, or (II) the additional use of such pesticide involves a minor food
or feed crop and the Administrator determines, with the concurrence of the Secretary
of Agriculture, there is available an effective alternative pesticide that does not
meet or exceed such risk criteria. An applicant seeking amended registration under
this subparagraph shall submit such data as would be required to obtain registration
of a similar pesticide under paragraph (5). If the applicant is unable to submit an
item of data (other than data pertaining to the proposed additional use) because it
has not yet been generated, the Administrator may amend the registration under such
conditions as will require the submission of such data not later than the time such
data are required to be submitted with respect to similar pesticides already
registered under this Act.
(C) The Administrator may conditionally register a pesticide containing an active
ingredient not contained in any currently registered pesticide for a period reasonably
sufficient for the generation and submission of required data (which are lacking
because a period reasonably sufficient for generation of the data has not elapsed
since the Administrator first imposed the data requirement) on the condition that by
the end of such period the Administrator receives such data and the data do not meet
or exceed risk criteria enumerated in regulations issued under this Act, and on such
other conditions as the Administrator may prescribe. A conditional registration under
this subparagraph shall be granted only if the Administrator determines that use of
the pesticide during such period will not cause any unreasonable adverse effect on
the environment, and that use of the pesticide is in the public interest.
(8) Interim Administrative Review.--Notwithstanding any other provision of this Act,
the Administrator may not initiate a public interim administrative review process to
develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses
prior to initiating a formal action to cancel, suspend, or deny registration of such
pesticide, required under this Act, unless such interim administrative process is based
on a validated test or other significant evidence raising prudent concerns of
unreasonable adverse risk to man or to the environment. Notice of the definition of the
terms "validated test" and "other significant evidence" as used herein shall be published
by the Administrator in the Federal Register.
(9)Labeling.--
(A) Additional Statements.--Subject to subparagraphs (B) and (C), it shall not
be a violation of this Act for a registrant to modify the labeling of an
antimicrobial pesticide product to include relevant information on product efficacy,
product composition, container composition or design, or other characteristics that do
not relate to any pesticidal claim or pesticidal activity.
(B) Requirements.--Proposed labeling information under subparagraph (A) shall not
be false or misleading, shall not conflict with or detract from any statement required
by law or the Administrator as a condition of registration, and shall be substantiated
on the request of the Administrator.
(C) Notification and Disapproval.--
(i) Notification.--A registration may be modified under subparagraph (A) if -
(I) the registrant notifies the Administrator in writing not later than 60
days prior to distribution or sale of a product bearing the modified labeling;
and
(II) the Administrator does not disapprove of the modification under clause
(ii).
(ii) Disapproval.--Not later than 30 days after receipt of a notification
under clause (i), the Administrator may disapprove the modification by sending
the registrant notification in writing stating that the proposed language is not
acceptable and stating the reasons why the Administrator finds the proposed
modification unacceptable.
(iii) Restriction on Sale.--A registrant may not sell or distribute a product
bearing a disapproved modification.
(iv) Objection.--A registrant may file an objection in writing to a
disapproval under clause (ii) not later than 30 days after receipt of notification
of the disapproval.
(v) Final Action.--A decision by the Administrator following receipt and
consideration of an objection filed under clause (iv) shall be considered a final
agency action.
(D) Use Dilution.--The label or labeling required under this Act for an
antimicrobial pesticide that is or may be diluted for use may have a different
statement of caution or protective measures for use of the recommended diluted
solution of the pesticide than for use of a concentrate of the pesticide if the
Administrator determines that -
(i) adequate data have been submitted to support the statement proposed for
the diluted solution uses; and
(ii) the label or labeling provides adequate protection for exposure to the
diluted solution of the pesticide.
(10) Expedited Registration of Pesticides.--
(A) Not later than 1 year after the date of enactment of this paragraph, the
Administrator shall, utilizing public comment, develop procedures and guidelines, and
expedite the review of an application for registration of a pesticide or an amendment
to a registration that satisfies such guidelines.
(B) Any application for registration or an amendment, including biological and
conventional pesticides, will be considered for expedited review under this paragraph.
An application for registration or an amendment shall qualify for expedited review if
use of the pesticide proposed by the application may reasonably be expected to
accomplish 1 or more of the following:
(i) Reduce the risks of pesticides to human health.
(ii) Reduce the risks of pesticides to nontarget organisms.
(iii) Reduce the potential for contamination of groundwater, surface water, or
other valued environmental resources.
(iv) Broaden the adoption of integrated pest management strategies, or make
such strategies more available or more effective.
(C) The Administrator, not later than 30 days after receipt of an application for
expedited review, shall notify the applicant whether the application is complete. If
it is found to be incomplete, the Administrator may either reject the request for
expedited review or ask the applicant for additional information to satisfy the
guidelines developed under subparagraph (A).
(d) Classification of Pesticides.--
(1) Classification for General Use, Restricted Use, or Both.--
(A) As a part of the registration of a pesticide the
Administrator shall classify it as being for general use or for
restricted use. If the Administrator determines that some of the
uses for which the pesticide is registered should be for general use
and that other uses for which it is registered should be for
restricted use, the Administrator shall classify it for both general
use and restricted use. Pesticide uses may be classified by
regulation on the initial classification, and registered pesticides
may be classified prior to reregistration. If some of the uses of
the pesticide are classified for general use, and other uses are
classified for restricted use, the directions relating to its
general uses shall be clearly separated and distinguished from those
directions relating to its restricted uses. The Administrator may
require that its packaging and labeling for restricted uses shall be
clearly distinguishable from its packaging and labeling for general
uses.
(B) If the Administrator determines that the pesticide, when
applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one or
more of such uses, or in accordance with a widespread and commonly
recognized practice, will not generally cause unreasonable adverse
effects on the environment, the Administrator will classify the
pesticide, or the particular use or uses of the pesticide to which
the determination applies, for general use.
(C) If the Administrator determines that the pesticide, when
applied in accordance with its directions for use, warnings and
cautions and for the uses for which it is registered, or for one or
more of such uses, or in accordance with a widespread and commonly
recognized practice, may generally cause, without additional
regulatory restrictions, unreasonable adverse effects on the
environment, including injury to the applicator, the Administrator
shall classify the pesticide, or the particular use or uses to which
the determination applies, for restricted use:
(i) If the Administrator classifies a pesticide, or one or
more uses of such pesticide, for restricted use because of a
determination that the acute dermal or inhalation toxicity of
the pesticide presents a hazard to the applicator or other
persons, the pesticide shall be applied for any use to which the
restricted classification applies only by or under the direct
supervision of a certified applicator.
(ii) If the Administrator classifies a pesticide, or one or
more uses of such pesticide, for restricted use because of a
determination that its use without additional regulatory
restriction may cause unreasonable adverse effects on the
environment, the pesticide shall be applied for any use to which
the determination applies only by or under the direct
supervision of a certified applicator, or subject to such other
restrictions as the Administrator may provide by regulation. Any
such regulation shall be reviewable in the appropriate court of
appeals upon petition of a person adversely affected filed
within 60 days of the publication of the regulation in final
form.
(2) Change in Classification.--If the Administrator determines that a change in
the classification of any use of a pesticide from general use to
restricted use is necessary to prevent unreasonable adverse effects
on the environment, the Administrator shall notify the registrant of
such pesticide of such determination at least forty-five days before
making the change and shall publish the proposed change in the
Federal Register. The registrant, or other interested person with
the concurrence of the registrant, may seek relief from such
determination under section 6(b).
(3) Change in Classification from Restricted Use to General Use.--The registrant of
any pesticide with one or more uses classified for restricted use may petition
the Administrator to change any such classification from restricted to general
use. Such petition shall set out the basis for the registrant's position that restricted
use classification is unnecessary because classification of the pesticide for general
use would not cause unreasonable adverse effects on the environment. The Administrator,
within sixty days after receiving such petition, shall notify the registrant whether
the petition has been granted or denied. Any denial shall contain an explanation
therefor and any such denial shall be subject to judicial review under section 16 of
this Act.
(e) Products with Same Formulation and Claims.--Products which have the same formulation,
are manufactured by the same person, the labeling of which contains the same claims, and
the labels of which bear a designation identifying the product as the same pesticide may
be registered as a single pesticide; and additional names and labels shall be added to
the registration by supplemental statements.
(f) Miscellaneous.--
(1) Effect of Change of Labeling or Formulation.--If the labeling or formulation for a
pesticide is changed, the registration shall be amended to reflect such change if the
Administrator determines that the change will not violate any provision of this Act.
(2) Registration Not a Defense.--In no event shall registration of an article be
construed as a defense for the commission of any offense under this Act. As long as no
cancellation proceedings are in effect registration of a pesticide shall be prima facie
evidence that the pesticide, its labeling and packaging comply with the registration
provisions of the Act.
(3) Authority to Consult Other Federal Agencies.--In connection with consideration of
any registration or application for registration under this section, the Administrator may
consult with any other Federal agency.
(4) Mixtures of Nitrogen Stabilizers and Fertilizer Products.--Any mixture or other
combination of--
(A) 1 or more nitrogen stabilizers registered under this Act; and
(B) 1 or more fertilizer products,
shall not be subject to the provisions of this section or sections 4, 5, 7, 15, and
17(a)(2) if the mixture or other combination is accompanied by the labeling required
under this Act for the nitrogen stabilizer contained in the mixture or other combination,
the mixture or combination is mixed or combined in accordance with such labeling, and
the mixture or combination does not contain any active ingredient other than the
nitrogen stabilizer.
(g) Registration Review.--
(1)(A) General Rule.--The registrations of pesticides are to be periodically
reviewed. The Administrator shall by regulation establish a procedure for accomplishing
the periodic review of registrations. The goal of these regulations shall be a review of
a pesticide's registration every 15 years. No registration shall be canceled as a result
of the registration review process unless the Administrator follows the procedures and
substantive requirements of section 6.
(B) Limitation.--Nothing in this subsection shall prohibit the Administrator from
undertaking any other review of a pesticide pursuant to this Act.
(2)(A) Data.--The Administrator shall use the authority in subsection (c)(2)(B) to
require the submission of data when such data are necessary for a registration review.
(B) Data Submission, Compensation, and Exemption.--For purposes of this subsection,
the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and
be applicable to any data required for registration review.
(h) Registration Requirements for Antimicrobial Pesticides.--
(1) Evaluation of Process.--To the maximum extent practicable consistent with the
degrees of risk presented by an antimicrobial pesticide and the type of review appropriate
to evaluate the risks, the Administrator shall identify and evaluate reforms to the
antimicrobial registration process that would reduce review periods existing as of the
date of enactment of this subsection for antimicrobial pesticide product registration
applications and applications for amended registration of antimicrobial pesticide
products, including--
(A) new antimicrobial active ingredients;
(B) new antimicrobial end-use products;
(C) substantially similar or identical antimicrobial pesticides; and
(D) amendments to antimicrobial pesticide registrations.
(2) Review Time Period Reduction Goal.--Each reform identified under paragraph (1)
shall be designed to achieve the goal of reducing the review period following submission
of a complete application, consistent with the degree of risk, to a period of not more
than--
(A) 540 days for a new antimicrobial active ingredient pesticide registration;
(B) 270 days for a new antimicrobial use of a registered active ingredient;
(C) 120 days for any other new antimicrobial product;
(D) 90 days for a substantially similar or identical antimicrobial product;
(E) 90 days for an amendment to an antimicrobial registration that does not
require scientific review of data; and
(F) 90 to 180 days for an amendment to an antimicrobial registration that requires
scientific review of data and that is not otherwise described in this paragraph.
(3) Implementation.--
(A) Proposed Rulemaking.--
(i) Issuance.--Not later than 270 days after the date of enactment of this
subsection, the Administrator shall publish in the Federal Register proposed
regulations to accelerate and improve the review of antimicrobial pesticide
products designed to implement, to the extent practicable, the goals set forth
in paragraph (2).
(ii) Requirements.--Proposed regulations issued under clause (i) shall--
(I) define the various classes of antimicrobial use patterns, including
household, industrial, and institutional disinfectants and sanitizing
pesticides, preservatives, water treatment, and pulp and paper mill additives,
and other such products intended to disinfect, sanitize, reduce, or mitigate
growth or development of microbiological organisms, or protect inanimate
objects, industrial processes or systems, surfaces, water, or other chemical
substances from contamination, fouling, or deterioration caused by bacteria,
viruses, fungi, protozoa, algae, or slime;
(II) differentiate the types of review undertaken for antimicrobial
pesticides;
(III) conform the degree and type of review to the risks and benefits
presented by antimicrobial pesticides and the function of review under this
Act, considering the use patterns of the product, toxicity, expected exposure,
and product type;
(IV) ensure that the registration process is sufficient to maintain
antimicrobial pesticide efficacy and that antimicrobial pesticide products
continue to meet product performance standards and effectiveness levels for
each type of label claim made; and
(V) implement effective and reliable deadlines for process management.
(iii) Comments.--In developing the proposed regulations, the Administrator
shall solicit the views from registrants and other affected parties to maximize
the effectiveness of the rule development process.
(B) Final Regulations.--
(i) Issuance.--The Administrator shall issue final regulations not later than
240 days after the close of the comment period for the proposed regulations.
(ii) Failure to Meet Goal.--If a goal described in paragraph (2) is not met by
the final regulations, the Administrator shall identify the goal, explain why the
goal was not attained, describe the element of the regulations included instead,
and identify future steps to attain the goal.
(iii) Requirements.--In issuing final regulations, the Administrator shall--
(I) consider the establishment of a certification process for regulatory
actions involving risks that can be responsibly managed, consistent with the
degree of risk, in the most cost-efficient manner;
(II) consider the establishment of a certification process by approved
laboratories as an adjunct to the review process;
(III) use all appropriate and cost-effective review mechanisms,
including--
(aa) expanded use of notification and non-notification procedures;
(bb) revised procedures for application review; and
(cc) allocation of appropriate resources to ensure streamlined
management of antimicrobial pesticide registrations; and
(IV) clarify criteria for determination of the completeness of an
application.
(C) Expedited Review.--This subsection does not affect the requirements or extend
the deadlines or review periods contained in subsection (c)(3).
(D) Alternative Review Periods.--If the final regulations to carry out this
paragraph are not effective 630 days after the date of enactment of this subsection,
until the final regulations become effective, the review period, beginning on the
date of receipt by the Agency of a complete application, shall be -
(i) 2 years for a new antimicrobial active ingredient pesticide registration;
(ii) 1 year for a new antimicrobial use of a registered active ingredient;
(iii) 180 days for any other new antimicrobial product;
(iv) 90 days for a substantially similar or identical antimicrobial product;
(v) 90 days for an amendment to an antimicrobial registration that does not
require scientific review of data; and
(vi) 240 days for an amendment to an antimicrobial registration that requires
scientific review of data and that is not otherwise described in this
subparagraph.
(E) Wood Preservatives.--An application for the registration, or for an amendment
to the registration, of a wood preservative product for which a claim of pesticidal
activity listed in section 2(mm) of this is made (regardless of any other pesticidal
claim that is made with respect to the product) shall be reviewed by the Administrator
within the same period as that established under this paragraph for an antimicrobial
pesticide product application, consistent with the degree of risk posed by the use of
the wood preservative product, if the application requires the applicant to satisfy
the same data requirements as are required to support an application for a wood
preservative product that is an antimicrobial pesticide.
(F) Notification.--
(i) In General.--Subject to clause (iii), the Administrator shall notify an
applicant whether an application has been granted or denied not later than the
final day of the appropriate review period under this paragraph, unless the
applicant and the Administrator agree to a later date.
(ii) Final Decision.--If the Administrator fails to notify an applicant within
the period of time required under clause (i), the failure shall be considered an
agency action unlawfully withheld or unreasonably delayed for purposes of judicial
review under chapter 7 of title 5, United States Code.
(iii) Exemption.--This subparagraph does not apply to an application for an
antimicrobial pesticide that is filed under subsection (c)(3)(B) prior to 90 days
after the date of enactment of this subsection.
(4) Annual Report.--
(A) Submission.--Beginning on the date of enactment of this subsection and ending
on the date that the goals under paragraph (2) are achieved, the Administrator shall,
not later than March 1 of each year, prepare and submit an annual report to the
Committee on Agriculture of the House of Representatives and the Committee on
Agriculture, Nutrition, and Forestry of the Senate.
(B) Requirements.--A report submitted under subparagraph (A) shall include a
description of--
(i) measures taken to reduce the backlog of pending registration applications;
(ii) progress toward achieving reforms under this subsection; and
(iii) recommendations to improve the activities of the Agency pertaining to
antimicrobial registrations.

Sec. 4. [136a-1] Reregistration of Registered Pesticides.
(a) General Rule.--The Administrator shall reregister, in accordance with this section,
each registered pesticide containing any active ingredient contained in any pesticide
first registered before November 1, 1984, except for any pesticide as to which the
Administrator has determined, after November 1, 1984, and before the effective date of
this section, that--
(1) there are no outstanding data requirements; and
(2) the requirements of section 3(c)(5) of this title have been satisfied.
(b) Reregistration Phases.--Reregistrations of pesticides under this section shall be
carried out in the following phases:
(1) The first phase shall include the listing under subsection
(c) of the active ingredients of the pesticides that will be reregistered.
(2) The second phase shall include the submission to the
Administrator under subsection (d) of notices by registrants
respecting their intention to seek reregistration,
identification by registrants of missing and inadequate data for
such pesticides, and commitments by registrants to replace such
missing or inadequate data within the applicable time period.
(3) The third phase shall include submission to the
Administrator by registrants of the information required under
subsection (e).
(4) The fourth phase shall include an independent, initial
review by the Administrator under subsection (f) of
submissions under phases two and three, identification of
outstanding data requirements, and the issuance, as necessary, of
requests for additional data.
(5) The fifth phase shall include the review by the
Administrator under subsection (g) of data submitted
for reregistration and appropriate regulatory action by the
Administrator.
(c) Phase One.--
(1) Priority for Reregistration.--For purposes of the reregistration of the
pesticides described in subsection (a), the Administrator shall list the active
ingredients of pesticides and shall give priority to, among others, active ingredients
(other than active ingredients for which registration standards have been issued
before the effective date of this section) that--
(A) are in use on or in food or feed and may result in
postharvest residues;
(B) may result in residues of potential toxicological
concern in potable ground water, edible fish, or shellfish;
(C) have been determined by the Administrator before the
effective date of this section to have significant outstanding
data requirements; or
(D) are used on crops, including in greenhouses and
nurseries, where worker exposure is most likely to occur.
(2) Reregistration Lists.--For purposes of reregistration under this section, the
Administrator shall by order--
(A) not later than 70 days after the effective date of this
section, list pesticide active ingredients for which
registration standards have been issued before such effective
date;
(B) not later than 4 months after such effective date, list
the first 150 pesticide active ingredients, as determined under
paragraph (1);
(C) not later than 7 months after such effective date, list
the second 150 pesticide active ingredients, as determined under
paragraph (1); and
(D) not later than 10 months after such effective date, list
the remainder of the pesticide active ingredients, as determined
under paragraph (1).
Each list shall be published in the Federal Register.
(3) Judicial Review.--The content of a list issued by the Administrator under
paragraph (2) shall not be subject to judicial review.
(4) Notice to Registrants.--On the publication of a list of pesticide active
ingredients under paragraph (2), the Administrator shall send by certified mail
to the registrants of the pesticides containing such active
ingredients a notice of the time by which the registrants are to
notify the Administrator under subsection (d) whether the registrants intend
to seek or not to seek reregistration of such pesticides.
(d) Phase Two.--
(1) In General.--The registrant of a pesticide that contains an active ingredient
listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall submit to the
Administrator, within the time period prescribed by paragraph (4), the notice
described in paragraph (2) and any information, commitment, or offer described in
paragraph (3).
(2) Notice of Intent to Seek or Not to Seek Reregistration.--
(A) The registrant of a pesticide containing an active
ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) shall notify the Administrator by certified mail whether
the registrant intends to seek or does not intend to seek reregistration of
the pesticide.
(B) If a registrant submits a notice under subparagraph (A) of
an intention not to seek reregistration of a pesticide, the
Administrator shall publish a notice in the Federal Register stating
that such a notice has been submitted.
(3) Missing or Inadequate Data.--Each registrant of a pesticide that contains an
active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) and
for which the registrant submitted a notice under paragraph (2) of an intention to
seek reregistration of such pesticide shall submit to the Administrator--
(A) in accordance with regulations issued by the
Administrator under section 3, an identification of--
(i) all data that are required by regulation to support
the registration of the pesticide with respect to such
active ingredient;
(ii) data that were submitted by the registrant
previously in support of the registration of the pesticide
that are inadequate to meet such regulations; and
(iii) data identified under clause (i) that have not
been submitted to the Administrator; and
(B) either--
(i) a commitment to replace the data identified under
subparagraph (A)(ii) and submit the data identified under
subparagraph (A)(iii) within the applicable time period
prescribed by paragraph (4)(B); or
(ii) an offer to share in the cost to be incurred by a
person who has made a commitment under clause (i) to replace
or submit the data and an offer to submit to arbitration as
described by section 3(c)(2)(B) with regard to such cost sharing.
For purposes of a submission by a registrant under subparagraph
(A)(ii), data are inadequate if the data are derived from a study
with respect to which the registrant is unable to make the
certification prescribed by subsection (e)(1)(G) that the registrant possesses or
has access to the raw data used in or generated by such study. For purposes of
a submission by a registrant under such subparagraph, data shall be considered to be
inadequate if the data are derived from a study submitted before
January 1, 1970, unless it is demonstrated to the satisfaction of
the Administrator that such data should be considered to support the
registration of the pesticide that is to be reregistered.
(4) Time Periods.--
(A) A submission under paragraph (2) or (3) shall be made--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B), not later than
3 months after the date of publication of the listing of such
active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C), not later than 3 months
after the date of publication of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D), not later than 3 months
after the date of publication of the listing of such active ingredient.
On application, the Administrator may extend a time period
prescribed by this subparagraph if the Administrator determines that
factors beyond the control of the registrant prevent the registrant
from complying with such period.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (3)(B) within a reasonable
period of time, as determined by the Administrator, but not more
than 48 months after the date the registrant submitted the
commitment. The Administrator, on application of a registrant, may
extend the period prescribed by the preceding sentence by no more
than 2 years if extraordinary circumstances beyond the control of
the registrant prevent the registrant from submitting data within
such prescribed period. Upon application of a registrant, the Administrator
shall, in the case of a minor use, extend the deadline for the production of
residue chemistry data under this subparagraph for data required solely to
support that minor use until the final deadline for submission of data
under this section for the other uses of the pesticide established as of
the date of enactment of the Food Quality Protection Act of 1996 if--
(i) the data to support other uses of the pesticide on a food
are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment./1/ If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for
the production of the data. If the Administrator determines
that the registrant is not meeting or has not met the schedule
for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or other
provisions of this section, as appropriate, regarding the continued
registration of the affected products with the minor use and shall
inform the public of such action. Notwithstanding the provisions of
this subparagraph, the Administrator may take action to modify or
revoke the extension under this subparagraph if the Administrator
determines that the extension for the minor use may cause an unreasonable
adverse effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
-----------------------------------------------------------------------------------------
/1/ Indentation of the following sentences of this subparagraph is so in
original (as added by sec. 201(c)(2) of P.L. 104-170). Probaly should be indented
the same as flush matter of this subparagraph.
-----------------------------------------------------------------------------------------
(5) Cancellation and Removal.--
(A) If the registrant of a pesticide does not submit a notice
under paragraph (2) or (3) within the time prescribed by paragraph
(4)(A), the Administrator shall issue a notice of intent to cancel
the registration of such registrant for such pesticide and shall
publish the notice in the Federal Register and allow 60 days for the
submission of comments on the notice. On expiration of such 60 days,
the Administrator, by order and without a hearing, may cancel the
registration or take such other action, including extension of
applicable time periods, as may be necessary to enable
reregistration of such pesticide by another person.
(B)(i) If--
(I) no registrant of a pesticide containing an active
ingredient listed under subsection (c)(2) notifies the
Administrator under paragraph (2) that the registrant
intends to seek reregistration of any pesticide containing
that active ingredient;
(II) no such registrant complies with paragraph (3)(A); or
(III) no such registrant makes a commitment under paragraph
(3)(B) to replace or submit all data described in clauses (ii)
and (iii) of paragraph (3)(A);
the Administrator shall publish in the Federal Register a notice of
intent to remove the active ingredient from the list established
under subsection (c)(2) and a notice of intent to cancel the
registrations of all pesticides containing such active
ingredient and shall provide 60 days for comment on such notice.
(ii) After the 60-day period has expired, the Administrator, by
order, may cancel any such registration without hearing, except that
the Administrator shall not cancel a registration under this
subparagraph if--
(I) during the comment period a person acquires the rights
of the registrant in that registration;
(II) during the comment period that person furnishes a
notice of intent to reregister the pesticide in accordance with
paragraph (2); and
(III) not later than 120 days after the publication of the
notice under this subparagraph, that person has complied with
paragraph (3) and the fee prescribed by subsection (i)(1) of
this section has been paid.
(6) Suspensions and Penalties.--The Administrator shall issue a notice of intent
to suspend the registration of a pesticide in accordance with the procedures
prescribed by section 3(c)(2)(B)(iv) if the Administrator determines that (A) progress
is insufficient to ensure the submission of the data required for such pesticide
under a commitment made under paragraph (3)(B) within the time period
prescribed by paragraph (4)(B) or (B) the registrant has not
submitted such data to the Administrator within such time period. If the registrant
does not commit to support a specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion to support uses of the pesticide
on a food, or if all uses of the pesticide are nonfood uses and
the registrant does not commit to support a specific minor use of
the pesticide but is supporting and providing data in a timely
and adequate fashion to support other nonfood uses of the
pesticide, the Administrator, at the written request of the
registrant, shall not take any action pursuant to this paragraph
in regard to such unsupported minor use until the final deadline
established as of the date of enactment of the Food Quality Protection
Act of 1996, for the submission of data under this section for the supported
uses identified pursuant to this paragraph unless the Administrator determines
that the absence of the data is significant enough to cause human health
or environmental concerns. On such a determination the Administrator may refuse
the request for extension by the registrant. Upon receipt of the request from
the registrant, the Administrator shall publish in the Federal Register a
notice of the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 6(f)(1). If the Administrator grants an extension
under this paragraph, the Administrator shall monitor the development of the
data for the uses being supported and shall ensure that the registrant is
meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with section
3(c)(2)(B)(iv) of this title regarding the continued
registration of the affected products with the minor and other
uses and shall inform the public of such action in accordance
with section 6(f)(2) of this title. Notwithstanding this
subparagraph, the Administrator may deny, modify, or revoke the
temporary extension under this paragraph if the Administrator
determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary
extension and establish a new effective date by which the minor
use shall be deleted from the registration.
(e) Phase Three.--
(1) Information about Studies.-- Each registrant of a pesticide that contains an
active ingredient listed under subparagraph (B), (C), or (D) of subsection
(c)(2) who has submitted a notice under subsection (d)(2) of an intent to seek the
reregistration of such pesticide shall submit, in accordance with the guidelines
issued under paragraph (4), to the Administrator--
(A) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
and considered by the registrant to be adequate to meet the
requirements of section 3 and the regulations
issued under such section;
(B) a summary of each study concerning the active ingredient
previously submitted by the registrant in support of the
registration of a pesticide containing such active ingredient
that may not comply with the requirements of section 3 and the
regulations issued under such section but which the registrant
asserts should be deemed to comply with such requirements and regulations;
(C) a reformat of the data from each study summarized under
subparagraph (A) or (B) by the registrant concerning chronic
dosing, oncogenicity, reproductive effects, mutagenicity,
neurotoxicity, teratogenicity, or residue chemistry of the
active ingredient that were submitted to the Administrator
before January 1, 1982;
(D) where data described in subparagraph (C) are not
required for the active ingredient by regulations issued under
section 3, a reformat of acute and subchronic dosing data
submitted by the registrant to the Administrator before
January 1, 1982, that the registrant considers to be
adequate to meet the requirements of section 3 and the
regulations issued under such section;
(E) an identification of data that are required to be
submitted to the Administrator under section 6(a)(2), indicating
an adverse effect of the pesticide;
(F) an identification of any other information available
that in the view of the registrant supports the registration;
(G) a certification that the registrant or the Administrator
possesses or has access to the raw data used in or generated by
the studies that the registrant summarized under subparagraph
(A) or (B);
(H) either--
(i) a commitment to submit data to fill each outstanding
data requirement identified by the registrant; or
(ii) an offer to share in the cost of developing such
data to be incurred by a person who has made a commitment
under clause (i) to submit such data, and an offer to submit
to arbitration as described by section 3(c)(2)(B) and
(I) evidence of compliance with section 3(c)(1)(D)(ii) and
regulations issued thereunder with regard to previously submitted
data as if the registrant were now seeking the original registration
of the pesticide.
A registrant who submits a certification under subparagraph (G) that
is false shall be considered to have violated this Act and
shall be subject to the penalties prescribed by section 14.
(2) Time Periods.--
(A) The information required by paragraph (1) shall be submitted
to the Administrator--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B), not later
than 12 months after the date of publication of the
listing of such active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C), not later
than 12 months after the date of publication of the
listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D), not later
than 12 months after the date of publication of the
listing of such active ingredient.
(B) A registrant shall submit data in accordance with a
commitment entered into under paragraph (1)(H) within a reasonable
period of time, as determined by the Administrator, but not more
than 48 months after the date the registrant submitted the
commitment under such paragraph. The Administrator, on application
of a registrant, may extend the period prescribed by the preceding
sentence by no more than 2 years if extraordinary circumstances
beyond the control of the registrant prevent the registrant from
submitting data within such prescribed period. Upon application of a
registrant, the Administrator shall, in the case of a minor use,
extend the deadline for the production of residue chemistry data under
this subparagraph for data required solely to support that minor use
until the final deadline for submission of data under this section for
the other uses of the pesticide established as of the date of enactment
of the Food Quality Protection Act of 1996 if--
(i) the data to support other uses of the pesticide on a food
are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment./1/ If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for
the production of the data. If the Administrator determines
that the registrant is not meeting or has not met the schedule
for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or
other provisions of this section, as appropriate,
regarding the continued registration of the affected products
with the minor use and shall inform the public of such action.
Notwithstanding the provisions of this subparagraph, the
Administrator may take action to modify or revoke the extension
under this subparagraph if the Administrator determines that
the extension for the minor use may cause an unreasonable
adverse effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
-----------------------------------------------------------------------------------------
/1/ Indentation of the following sentences of this subparagraph is so in original (as
added by sec. 201(c)(2) of P.L. 104-170). Probably should be indented the same as
flush matter of this subparagraph.
-----------------------------------------------------------------------------------------
(3) Cancellation.--
(A) If the registrant of a pesticide fails to submit the
information required by paragraph (1) within the time prescribed by
paragraph (2), the Administrator, by order and without hearing,
shall cancel the registration of such pesticide. If the
registrant does not commit to support a specific minor use of the
pesticide, but is supporting and providing data in a timely and
adequate fashion to support uses of the pesticide on a food, or
if all uses of the pesticide are nonfood uses and the registrant
does not commit to support a specific minor use of the pesticide
but is supporting and providing data in a timely and adequate
fashion to support other nonfood uses of the pesticide, the
Administrator, at the written request of the registrant, shall
not take any action pursuant to this subparagraph in regard to
such unsupported minor use until the final deadline established
as of the date of enactment of the Food Quality Protection Act of
1996 for the submission of data under this section for the supported uses
identified pursuant to this subparagraph unless the Administrator
determines that the absence of the data is significant enough to cause
human health or environmental concerns. On the basis of such determination,
the Administrator may refuse the request for extension by the registrant.
Upon receipt of the request from the registrant, the Administrator shall
publish in the Federal Register a notice of the receipt of the request and
the effective date upon which the uses not being supported will be
voluntarily deleted from the registration pursuant to section 6(f)(1).
If the Administrator grants an extension under this subparagraph,
the Administrator shall monitor the development of the data for
the uses being supported and shall ensure that the registrant is
meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with section
3(c)(2)(B)(iv) regarding the continued registration of the
affected products with the minor and other uses and shall inform
the public of such action in accordance with section 6(f)(2).
Notwithstanding this subparagraph, the Administrator may deny,
modify, or revoke the temporary extension under this subparagraph
if the Administrator determines that the continuation of the minor
use may cause an unreasonable adverse effect on the environment.
In the event of modification or revocation, the Administrator shall
provide, in writing, to the registrant a notice revoking the temporary
extension and establish a new effective date by which the minor
use shall be deleted from the registration.
(B)(i) If the registrant of a pesticide submits the information
required by paragraph (1) within the time prescribed by paragraph
(2) and such information does not conform to the guidelines for
submissions established by the Administrator, the Administrator
shall determine whether the registrant made a good faith attempt to
conform its submission to such guidelines.
(ii) If the Administrator determines that the registrant made a
good faith attempt to conform its submission to such guidelines, the
Administrator shall provide the registrant a reasonable period of
time to make any necessary changes or corrections.
(iii)(I) If the Administrator determines that the registrant did
not make a good faith attempt to conform its submission to such
guidelines, the Administrator may issue a notice of intent to cancel
the registration. Such a notice shall be sent to the registrant by
certified mail.
(II) The registration shall be canceled without a hearing or
further notice at the end of 30 days after receipt by the registrant
of the notice unless during that time a request for a hearing is
made by the registrant.
(III) If a hearing is requested, a hearing shall be conducted
under section 6(d), except that the only matter for resolution at
the hearing shall be whether the registrant made a good faith
attempt to conform its submission to such guidelines. The
hearing shall be held and a determination made within 75 days after
receipt of a request for hearing.
(4) Guidelines.--
(A) Not later than 1 year after the effective date of this
section, the Administrator, by order, shall issue guidelines to be
followed by registrants in--
(i) summarizing studies;
(ii) reformatting studies;
(iii) identifying adverse information; and
(iv) identifying studies that have been submitted previously
that may not meet the requirements of section 3 or regulations
issued under such section, under paragraph (1).
(B) Guidelines issued under subparagraph (A) shall not be
subject to judicial review.
(5) Monitoring.--The Administrator shall monitor the progress of registrants
in acquiring and submitting the data required under paragraph (1).
(f) Phase Four.--
(1) Independent Review and Identification of Outstanding Data Requirements.--
(A) The Administrator shall review the submissions of all
registrants of pesticides containing a particular active ingredient
under subsections (d)(3) and (e)(1) to determine if such submissions
identified all the data that are missing or inadequate for such active
ingredient. To assist the review of the Administrator under this subparagraph,
the Administrator may require a registrant seeking reregistration to submit
complete copies of studies summarized under subsection (e)(1).
(B) The Administrator shall independently identify and publish
in the Federal Register the outstanding data requirements for each
active ingredient that is listed under subparagraph (B), (C), or (D)
of subsection (c)(2) and that is contained in a pesticide to be
reregistered under this section. The Administrator, at the same time,
shall issue a notice under section 3(c)(2)(B) for the submission of the
additional data that are required to meet such requirements.
(2) Time Periods.--
(A) The Administrator shall take the action required by
paragraph (1)--
(i) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(B), not later than
18 months after the date of the listing of such active ingredient;
(ii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(C), not later than
24 months after the date of the listing of such active ingredient; and
(iii) in the case of a pesticide containing an active
ingredient listed under subsection (c)(2)(D), not later than
33 months after the date of the listing of such active ingredient.
(B) If the Administrator issues a notice to a registrant under
paragraph (1)(B) for the submission of additional data, the
registrant shall submit such data within a reasonable period of
time, as determined by the Administrator, but not to exceed 48
months after the issuance of such notice. The Administrator, on
application of a registrant, may extend the period prescribed by the
preceding sentence by no more than 2 years if extraordinary
circumstances beyond the control of the registrant prevent the
registrant from submitting data within such prescribed period.
Upon application of a registrant, the Administrator shall, in the
case of a minor use, extend the deadline for the production of
residue chemistry data under this subparagraph for data required
solely to support that minor use until the final deadline for
submission of data under this section for the other uses of the
pesticide established as of the date of enactment of the Food Quality
Protection Act of 1996 if--
(i) the data to support other uses of the pesticide on a food
are being provided;
(ii) the registrant, in submitting a request for such an
extension provides a schedule, including interim dates to
measure progress, to assure that the data production will be
completed before the expiration of the extension period;
(iii) the Administrator has determined that such extension
will not significantly delay the Administrator's schedule for
issuing a reregistration eligibility determination required
under this section; and
(iv) the Administrator has determined that based on existing
data, such extension would not significantly increase the risk
of any unreasonable adverse effect on the environment./1/ If the
Administrator grants an extension under this subparagraph, the
Administrator shall monitor the development of the data and
shall ensure that the registrant is meeting the schedule for
the production of the data. If the Administrator determines
that the registrant is not meeting or has not met the schedule
for the production of such data, the Administrator may proceed
in accordance with clause (iv) of section 3(c)(2)(B) or other
provisions of this section, as appropriate, regarding the continued
registration of the affected products with the minor use and shall
inform the public of such action. Notwithstanding the provisions of
this subparagraph, the Administrator may take action to modify or
revoke the extension under this subparagraph if the Administrator
determines that the extension for the minor use may cause an unreasonable
adverse effect on the environment. In such circumstance, the
Administrator shall provide written notice to the registrant
revoking the extension of time for submission of data. Such
data shall instead be due in accordance with the date then
established by the Administrator for submission of the data.
-----------------------------------------------------------------------------------------
/1/ Indentation of the following sentences of this subparagraph is so in original (as
added by sec. 201(c)(2) of P.L. 104-170). Probably should be indented the same as
flush matter of this subparagraph.
-----------------------------------------------------------------------------------------
(3) Suspensions and Penalties.--The Administrator shall issue a notice of
intent to suspend the registration of a pesticide in accordance with the procedures
prescribed by section 3(c)(2)(B)(iv) if the Administrator determines that (A)
tests necessary to fill an outstanding data requirement for such pesticide have
not been initiated within 1 year after the issuance of a notice under
paragraph (1)(B), or (B) progress is insufficient to ensure
submission of the data referred to in clause (A) within the time
period prescribed by paragraph (2)(B) or the required data have not
been submitted to the Administrator within such time period. If the registrant does
not commit to support a specific minor use of the pesticide, but is supporting
and providing data in a timely and adequate fashion to support uses of the
pesticide on a food, or if all uses of the pesticide are nonfood uses and the
registrant does not commit to support a specific minor use of the
pesticide but is supporting and providing data in a timely and
adequate fashion to support other nonfood uses of the pesticide,
the Administrator, at the written request of the registrant,
shall not take any action pursuant to this paragraph in regard to
such unsupported minor use until the final deadline established
as of the date of enactment of the Food Quality Protection Act of 1996, for the
submission of data under this section for the supported uses identified pursuant to
this paragraph unless the Administrator determines that the absence of the data
is significant enough to cause human health or environmental concerns. On such a
determination the Administrator may refuse the request for extension by the
registrant. Upon receipt of the request from the registrant, the
Administrator shall publish in the Federal Register a notice of
the receipt of the request and the effective date upon which the
uses not being supported will be voluntarily deleted from the
registration pursuant to section 6(f)(1). If the Administrator grants an
extension under this paragraph, the Administrator shall monitor the
development of the data for the uses being supported and shall ensure that
the registrant is meeting the schedule for the production of such data. If the
Administrator determines that the registrant is not meeting or
has not met the schedule for the production of such data, the
Administrator may proceed in accordance with section 3(c)(2)(B)(iv) regarding the
continued registration of the affected products with the minor and other
uses and shall inform the public of such action in accordance
with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may
deny, modify, or revoke the temporary extension under this paragraph if the
Administrator determines that the continuation of the minor use may cause an
unreasonable adverse effect on the environment. In the event of
modification or revocation, the Administrator shall provide, in
writing, to the registrant a notice revoking the temporary
extension and establish a new effective date by which the minor
use shall be deleted from the registration.
(g) Phase Five.--
(1) Data Review.--The Administrator shall conduct a thorough examination
of all data submitted under this section concerning an active ingredient
listed under subsection (c)(2) of this section and of all other available data
found by the Administrator to be relevant.
(2) Reregistration and Other Actions.--
(A) Within 1 year after the submission of all data concerning an
active ingredient of a pesticide under subsection (f), the Administrator
shall determine whether pesticides containing such active ingredient are
eligible for reregistration. For extraordinary circumstances, the
Administrator may extend such period for not more than 1 additional year.
(B) Before reregistering a pesticide, the Administrator shall
obtain any needed product-specific data regarding the pesticide by
use of section 3(c)(2)(B) and shall review such data within 90 days after
its submission. The Administrator shall require that data under this
subparagraph be submitted to the Administrator not later than 8 months
after a determination of eligibility under subparagraph (A) has been made for
each active ingredient of the pesticide, unless the Administrator determines
that a longer period is required for the generation of the data.
(C) After conducting the review required by paragraph (1) for
each active ingredient of a pesticide and the review required by
subparagraph (B) of this paragraph, the Administrator shall
determine whether to reregister a pesticide by determining whether
such pesticide meets the requirements of section 3(c)(5). If the Administrator
determines that a pesticide is eligible to be reregistered, the Administrator
shall reregister such pesticide within 6 months after the submission of the
data concerning such pesticide under subparagraph (B).
(D) If after conducting a review under paragraph (1) or
subparagraph (B) of this paragraph the Administrator determines that
a pesticide should not be reregistered, the Administrator shall take
appropriate regulatory action.
(E) As soon as the Administrator has sufficient information
with respect to the dietary risk of a particular active ingredient, but in
any event no later than the time the Administrator makes a determination under
subparagraph (C) or (D) with respect to pesticides containing a particular
active ingredient, the Administrator shall--
(i) reassess each associated tolerance and exemption from the
requirement for a tolerance issued under section 408 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);
(ii) determine whether such tolerance or exemption meets the
requirements of that Act;
(iii) determine whether additional tolerances or exemptions
should be issued;
(iv) publish in the Federal Register a notice setting forth
the determinations made under this subparagraph; and
(v) commence promptly such proceedings under this Act
and section 408 of the Federal Food, Drug, and Cosmetic Act as are
warranted by such determinations.
(h) Compensation of Data Submitter.--If data that are submitted by a registrant
under subsection (d), (e), (f), or (g) of this section are used to support the
application of another person under section 136a of this title, the registrant
who submitted such data shall be entitled to compensation for the use of
such data as prescribed by section 136a(c)(1)(D) \2\ of this title. In
determining the amount of such compensation, the fees paid by the
registrant under this section shall be taken into account.
(i) Fees.--
(1) Initial Fee for Food or Feed Use Pesticide Active Ingredients.--The registrants
of pesticides that contain an active ingredient that is listed under subparagraph (B),
(C), or (D) of subsection (c)(2) of this section and that is an active ingredient of
any pesticide registered for a major food or feed use shall collectively pay a fee of
$50,000 on submission of information under paragraphs (2) and (3) of subsection (d) of
this section for such ingredient.
(2) Final Fee for Food or Feed Use Pesticide Active Ingredients.--
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D) of
subsection (c)(2) and that is an active ingredient of any pesticide
registered for a major food or feed use shall collectively pay a fee of $100,000--
(i) on submission of information for such ingredient under
subsection (e)(1) if data are reformatted under subsection (e)(1)(C); or
(ii) on submission of data for such ingredient under
subsection (e)(2)(B) if data are not reformatted under subsection (e)(1)(C).
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) and that is an active
ingredient of any pesticide registered for a major food or feed use shall
collectively pay a fee of $150,000 at such time as the Administrator shall
prescribe.
(3) Fees for Other Pesticide Active Ingredients.
(A) The registrants of pesticides that contain an active
ingredient that is listed under subparagraph (B), (C), or (D) of
subsection (c)(2) and that is not an active ingredient of any
pesticide registered for a major food or feed use shall collectively
pay fees in amounts determined by the Administrator. Such fees may
not be less than one-half of, nor greater than, the fees required by
paragraphs (1) and (2). A registrant shall pay such fees at the times
corresponding to the times fees prescribed by paragraphs (1) and (2)
are to be paid.
(B) The registrants of pesticides that contain an active
ingredient that is listed under subsection (c)(2)(A) and that is not
an active ingredient of any pesticide that is registered for a major
food or feed use shall collectively pay a fee of not more than $100,000
and not less than $50,000 at such time as the Administrator shall prescribe.
(4) Reduction or Waiver of Fees for Minor Use and Other Pesticides.
(A) An active ingredient that is contained only in pesticides
that are registered solely for agricultural or nonagricultural minor
uses, or a pesticide the value or volume of use of which is small,
shall be exempt from the fees prescribed by paragraph (3).
(B) The Administrator shall exempt any public health pesticide from
the payment of the fee prescribed under paragraph (3) if, in consultation
with the Secretary of Health and Human Services, the Administrator determines,
based on information supplied by the registrant, that the economic return to
the registrant from sales of the pesticide does not support the registration
or reregistration of the pesticide.
(C) An antimicrobial active ingredient, the production level of
which does not exceed 1,000,000 pounds per year, shall be exempt
from the fees prescribed by paragraph (3). For purposes of this
subparagraph, the term "antimicrobial active ingredient" means any
active ingredient that is contained only in pesticides that are not
registered for any food or feed use and that are--
(i) sanitizers intended to reduce the number of living
bacteria or viable virus particles on inanimate surface or in
water or air;
(ii) bacteriostats intended to inhibit the growth of
bacteria in the presence of moisture;
(iii) disinfectants intended to destroy or irreversibly
inactivate bacteria, fungi, or viruses on surfaces or inanimate
objects;
(iv) sterilizers intended to destroy viruses and all living
bacteria, fungi, and their spores on inanimate surfaces; or
(v) fungicides or fungistats.
(D)(i) Notwithstanding any other provision of this subsection,
in the case of a small business registrant of a pesticide, the
registrant shall pay a fee for the reregistration of each active
ingredient of the pesticide that does not exceed an amount
determined in accordance with this subparagraph.
(ii) If during the 3-year period prior to reregistration the
average annual gross revenue of the registrant from pesticides
containing such active ingredient is--
(I) less than $5,000,000, the registrant shall pay 0.5
percent of such revenue;
(II) $5,000,000 or more but less than $10,000,000, the
registrant shall pay 1 percent of such revenue; or
(III) $10,000,000 or more, the registrant shall pay 1.5
percent of such revenue, but not more than $150,000.
(iii) For the purpose of this subparagraph, a small business
registrant is a corporation, partnership, or unincorporated business
that--
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to reregistration, had
an average annual gross revenue from chemicals that did not
exceed $40,000,000.
(5) Maintenance Fee.--
(A) Subject to other provisions of this paragraph, each
registrant of a pesticide shall pay an annual fee by January 15 of
each year of--
(i) $650 for the first registration; and
(ii) $1,300 for each additional registration, except that no
fee shall be charged for more than 200 registrations held by any
registrant.
(B) In the case of a pesticide that is registered for a minor
agricultural use, the Administrator may reduce or waive the payment
of the fee imposed under this paragraph if the Administrator
determines that the fee would significantly reduce the availability
of the pesticide for the use.
(C)(i)/1/ The amount of each fee prescribed under subparagraph (A)
shall be adjusted by the Administrator to a level that will result
in the collection under this paragraph of, to the extent
practicable, an aggregate amount of $14,000,000 each fiscal year.
(ii)/1/ in /2/ each of the fiscal years 1998, 1999, and 2000, the Administrator
is authorized to collect up to an additional $2,000,000 in a manner
consistent with subsection (k)(5) and the recommendations of the Inspector
General of the Environmental Protection Agency. The total fees that
may be collected under this clause shall not exceed $6,000,000.
-----------------------------------------------------------------------------------------
/1/ Sec. 501(a)(2) of P.L. 104-170 amended para. (5)(C) of sec.
4(i) (7 U.S.C. 136a-1(i)) by inserting "(i)" after "(C)" and adding clause (ii), without
specifying the Act that was being amended. The amendments were executed to this Act to
effectuate the probable intent of Congress.
/2/ So in original (as added by sec. 501(a)(2) of P.L. 104-170). Probably should be
"In".
-----------------------------------------------------------------------------------------
(D) The maximum annual fee payable under this paragraph by--
(i) a registrant holding not more than 50 pesticide
registrations shall be $55,000; and
(ii) a registrant holding over 50 registrations shall be
$95,000.
(E)(i) For a small business, the maximum annual fee payable
under this paragraph by--
(I) a registrant holding not more than 50 pesticide
registrations shall be $38,500; and
(II) a registrant holding over 50 pesticide registrations
shall be $66,500.
(ii) For purposes of clause (i), the term "small business"
means a corporation, partnership, or unincorporated business that--
(I) has 150 or fewer employees; and
(II) during the 3-year period prior to the most recent
maintenance fee billing cycle, had an average annual gross
revenue from chemicals that did not exceed $40,000,000.
(F) The Administrator shall exempt any public health pesticide from
the payment of the fee prescribed under paragraph (3) if, in consultation
with the Secretary of Health and Humans /1/ Services, the Administrator determines,
based on information supplied with the registrant, that the economic return
to the registrant from sales of the pesticide does not support the registration
or reregistration of the pesticide.
(G) If any fee prescribed by this paragraph with respect to the
registration of a pesticide is not paid by a registrant by the time
prescribed, the Administrator, by order and without hearing, may
cancel the registration.
(H) The authority provided under this paragraph shall terminate
on September 30, 2001./2/
(6) Other Fees.--During the period beginning on October 25, 1988, and ending on
September 30, 2001,/2/ the Administrator may not levy any other fees
for the registration of a pesticide under this Act except as
provided in paragraphs (1) through (5).
-----------------------------------------------------------------------------------------
/1/ So in original (as added by sec. 232(2) of P.L. 104-170). Probably should be
"Human".
/2/ Sec. 501(a)(1) of P.L. 104-170 amended paras. (5)(H) and (6) of sec. 4(i) (7 U.S.C.
136a-1(i)) by striking "1997" and inserting "2001", without specifying the Act that was
being amended. The amendments were executed to this Act to effectuate the probable
intent of Congress.
-----------------------------------------------------------------------------------------
(7) Apportionment.--
(A) If two or more registrants are required to pay any fee
prescribed by paragraph (1), (2), or (3) with respect to a
particular active ingredient, the fees for such active ingredient
shall be apportioned among such registrants on the basis of the
market share in United States sales of the active ingredient for the
3 calendar years preceding the date of payment of such fee, except
that--
(i) small business registrants that produce the active
ingredient shall pay fees in accordance with paragraph (4)(C);
and
(ii) registrants who have no market share but who choose to
reregister a pesticide containing such active ingredient shall
pay the lesser of--
(I) 15 percent of the reregistration fee; or
(II) a proportionate amount of such fee based on the
lowest percentage market share held by any registrant active
in the marketplace.
In no event shall registrants who have no market share but who
choose to reregister a pesticide containing such active
ingredient collectively pay more than 25 percent of the total
active ingredient reregistration fee.
(B) The Administrator, by order, may require any registrant to
submit such reports as the Administrator determines to be necessary
to allow the Administrator to determine and apportion fees under
this subsection or to determine the registrant's eligibility for a
reduction or waiver of a fee, or to determine the volume usage for
public health pesticides.
(C) If any such report is not submitted by a registrant after
receiving notice of such report requirement, or if any fee
prescribed by this subsection (other than paragraph (5)) for an
active ingredient is not paid by a registrant to the Administrator
by the time prescribed under this subsection, the Administrator, by
order and without hearing, may cancel each registration held by such
registrant of a pesticide containing the active ingredient with
respect to which the fee is imposed. The Administrator shall
reapportion the fee among the remaining registrants and notify the
registrants that the registrants are required to pay to the
Administrator any unpaid balance of the fee within 30 days after
receipt of such notice.
(j) Exemption of Certain Registrants.--The requirements of subsections (d),
(e), (f), and (i) of this section (other than subsection (i)(5) of this
section) regarding data concerning an active ingredient and fees for review
of such data shall not apply to any person who is the registrant of a pesticide
to the extent that, under section 3(c)(2)(D), the person would not be required
to submit or cite such data to obtain an initial registration of such pesticide.
(k) Reregistration and Expedited Processing Fund.--
(1) Establishment.--There shall be established in the Treasury of the United
States a reregistration and expedited processing fund which shall be known as the
Reregistration and Expedited Processing Fund./1/
(2) /2/ Source and Use.--
(A) All moneys derived from fees collected by the Administrator
under subsection (i) shall be deposited in the fund and shall be
available to the Administrator, without fiscal year limitation,
specifically to offset the costs of reregistration and expedited
processing of the applications specified in paragraph (3). Such moneys
derived from fees may not be expended in any fiscal year to the extent
such moneys derived from fees would exceed money appropriated for use
by the Administrator and expended in such year for such costs of
reregistration and expedited processing of such applications. The
Administrator shall, prior to expending any such moneys derived from fees--
-----------------------------------------------------------------------------------------
/1/ Sec. 501(b) of P.L. 104-170 amended sec. 4(k)(1) (7 U.S.C. 136a-1(k)(1)) by
inserting "which shall be known as the Reregistration and Expedited Processing Fund",
without specifying the Act that was being amended. The amendment was executed to this
Act to effectuate the probable intent of Congress.
/2/ Sec. 501(b) of P.L. 104-170 amended sec. 4(k)(2) (7 U.S.C. 136a-1(k)(2)) to read as
provided above, without specifying the Act that was being amended. The amendment was
executed to this Act to effectuate the probable intent of Congress.
-----------------------------------------------------------------------------------------
(i) effective October 1, 1997, adopt specific and cost
accounting rules and procedures as approved by the General
Accounting Office and the Inspector General of the
Environmental Protection Agency to ensure that moneys derived
from fees are allocated solely to the costs of reregistration
and expedited processing of the applications specified in
paragraph (3) in the same portion as appropriated funds;
(ii) prohibit the use of such moneys derived from fees to pay
for any costs other than those necessary to achieve
reregistration and expedited processing of the applications
specified in paragraph (3); and
(iii) ensure that personnel and facility costs associated
with the functions to be carried out under this paragraph do
not exceed agency averages for comparable personnel and
facility costs.
(B) The Administrator shall also--
(i) complete the review of unreviewed reregistration studies
required to support the reregistration eligibility decisions
scheduled for completion in accordance with subsection (l)(2); and
(ii) contract for such outside assistance as may be necessary
for review of required studies, using a generally accepted
competitive process for the selection of vendors of such
assistance.
(3) Expedited Processing of Similar Applications.--
(A) The Administrator shall use for each of the fiscal years
1997 through 2001, not more than 1/7th of the maintenance fees collected
in such fiscal year /1/ to obtain sufficient personnel and resources
to assure the expedited processing and review of any application
that--
(i) proposes the initial or amended registration of an end-
use pesticide that, if registered as proposed, would be
identical or substantially similar in composition and labeling
to a currently-registered pesticide identified in the
application, or that would differ in composition and labeling
from any such currently-registered pesticide only in ways that
would not significantly increase the risk of unreasonable
adverse effects on the environment; or
(ii) proposes an amendment to the registration of a
registered pesticide that does not require scientific review of
data; or
(iii) proposes the initial or amended registration of an end
use pesticide that, if registered as proposed, would be used for a
public health pesticide.
-----------------------------------------------------------------------------------------
/1/ Sec. 501(d)(1) of P.L. 104-170 amended sec. 4(k)(3) (7 U.S.C. 136a-1(k)(3)) by
striking "for each of the fiscal years 1992, 1993, and 1994, 1/7th of the maintenance
fees collected, up to 2 million each year" and inserting "for each of the fiscal years
1997 through 2001, not more than 1/7 of the maintenance fees collected in such fiscal
year", without specifying the Act that was being amended and without including a $ before
"2 million". The amendment was executed to this Act, and to strike "$2 million", to
effectuate the probable intent of Congress.
-----------------------------------------------------------------------------------------
(B) Any amounts made available under subparagraph (A) shall be
used to obtain sufficient personnel and resources to carry out the
activities described in such subparagraph that are in addition to
the personnel and resources available to carry out such activities
on the date of enactment of this section.
(C)/1/ So long as the Administrator has not met the time frames
specified in clause (ii) of section 3(c)(3)(B) with respect
to any application subject to section 3(c)(3)(B) that was
received prior to the date of enactment of the Food Quality
Protection Act of 1996, the Administrator shall use the full
amount of the fees specified in subparagraph (A) for the purposes
specified therein. Once all applications subject to section 3(c)(3)(B)
that were received prior to such date of enactment have been acted upon,
no limitation shall be imposed by the preceding sentence of this
subparagraph so long as the Administrator meets the time frames
specified in clause (ii) of section 3(c)(3)(B) on 90 percent of
affected applications in a fiscal year. Should the Administrator not
meet such time frames in a fiscal year, the limitations imposed by
the first sentence of this subparagraph shall apply until all overdue
applications subject to section 3(c)(3)(B) have been acted upon.
(4) Unused Funds.--Money in the fund not currently needed to carry out this
section shall be--
(A) maintained on hand or on deposit;
(B) invested in obligations of the United States or guaranteed thereby; or
(C) invested in obligations, participations, or other instruments that are
lawful investments for fiduciary, trust, or public funds.
(5)/2/ Accounting and Performance.--The Administrator shall take all steps necessary to
ensure that expenditures from fees authorized by subsection (i)(5)(C)(ii) are used only to
carry out the goals established under subsection (l). The Reregistration and Expedited
Processing Fund shall be designated as an Environmental Protection Agency component for
purposes of section 3515(c) of title 31, United States Code. The annual audit required
under section 3521 of such title of the financial statements of activities under this Act
under section 3515(b) of such title shall include an audit of the fees collected under
subsection (i)(5)(C) and disbursed, of the amount appropriated to match such fees, and of
the Administrator's attainment of performance measures and goals established under
subsection (l). Such an audit shall also include a review of the reasonableness of the
overhead allocation and adequacy of disclosures of direct and indirect costs associated
with carrying out the reregistration and expedited processing of the applications
specified in paragraph (3), and the basis for and accuracy of all costs paid with moneys
derived from such fees. The Inspector General shall conduct the annual audit and report
the findings and recommendations of such audit to the Administrator and to the Committees
on Agriculture of the House of Representatives and the Senate. The cost of such audit
shall be paid for out of the fees collected under subsection (i)(5)(C).
-----------------------------------------------------------------------------------------
/1/ Sec. 501(d)(2) of P.L. 104-170 added subpara. (C) to sec. 4(k)(3) (7 U.S.C.
136a-1(k)(3)), without specifying the Act that was being amended. The amendment was
executed to this Act to effectuate the probable intent of Congress.
/2/ Sec. 501(e) of P.L. 104-170 amended sec. 4(k)(5) (7 U.S.C. 136a-1(k)(5)) to read as
provided above, without specifying the Act that was being amended. The amendment was
executed to this Act to effectuate the probable intent of Congress.
-----------------------------------------------------------------------------------------
(l)/1/ Performance Measures and Goals.--The Administrator shall establish and publish
annually in the Federal Register performance measures and goals. Such measures and
goals shall include--
(1) the number of products reregistered, canceled, or amended, the status of
reregistration, the number and type of data requests under section 3(c)(2)(B) issued to
support product reregistration by active ingredient, the progress in reducing the number
of unreviewed, required reregistration studies, the aggregate status of tolerances
reassessed, and the number of applications for registration submitted under subsection
(k)(3) that were approved or disapproved;
(2) the future schedule for reregistrations, including the projection for such
schedules that will be issued under subsection (g)(2)(A) and (B) in the current fiscal
year and the succeeding fiscal year; and
(3) the projected year of completion of the reregistrations under this section.
-----------------------------------------------------------------------------------------
/1/ Sec. 501(f) of P.L. 104-170 amended sec. 4 (7 U.S.C. 136a-1) by redesignating subsecs.
(l) and (m) as subsecs. (m) and (n), respectively, and inserting a new subsec. (l),
without specifying the Act that was being amended. The amendments were executed to this
Act to effectuate the probable intent of Congress.
-----------------------------------------------------------------------------------------
(m) Judicial Review.--Any failure of the Administrator to take any action required by this
section shall be subject to judicial review under the procedures prescribed by section
16(b).
(n) Authorization of Funds to Develop Public Health Data.--
(1) Definition.-- For the purposes of this section, "Secretary" means the Secretary of
Health and Human Services, acting through the Public Health Service.
(2) Consultation.--In the case of a pesticide registered for use in public health
programs for vector control or for other uses the Administrator determines to be human
health protection uses, the Administrator shall, upon timely request by the registrant or
any other interested person, or on the Administrator's own initiative may, consult with
the Secretary prior to taking final action to suspend registration under section
3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e), or 6(f). In consultation
with the Secretary, the Administrator shall prescribe the form and content of requests
under this section.
(3) Benefits to Support Family.--The Administrator, after consulting with the
Secretary, shall make a determination whether the potential benefits of continued use
of the pesticide for public health or health protection purposes are of such significance
as to warrant a commitment by the Secretary to conduct or to arrange for the conduct of
the studies required by the Administrator to support continued registration under section
3 or reregistration under section 4.
(4) Additional Time.--If the Administrator determines that such a commitment is
warranted and in the public interest, the Administrator shall notify the Secretary and
shall, to the extent necessary, amend a notice issued under section 3(c)(2)(B) to specify
additional reasonable time periods for submission of the data.
(5) Arrangements.--The Secretary shall make such arrangements for the conduct of
required studies as the Secretary finds necessary and appropriate to permit submission
of data in accordance with the time periods prescribed by the Administrator. Such
arrangements may include Public Health Service intramural research activities, grants,
contracts, or cooperative agreements with academic, public health, or other organizations
qualified by experience and training to conduct such studies.
(6) Support.--The Secretary may provide for support of the required studies using
funds authorized to be appropriated under this section, the Public Health Service Act,
or other appropriate authorities. After a determination is made under subsection (d),
the Secretary shall notify the Committees on Appropriations of the House of
Representatives and the Senate of the sums required to conduct the necessary studies.
(7) Authorization of Appropriations.--There is authorized to be appropriated to carry
out the purposes of this section $12,000,000 for fiscal year 1997, and such sums as may be
necessary for succeeding fiscal years.

Sec. 5 [136c] Experimental Use Permits.
(a) Issuance.--Any person may apply to the Administrator for an experimental use
permit for a pesticide. The Administrator shall review the application.
After completion of the review, but not later than one hundred and
twenty days after receipt of the application and all required supporting
data, the Administrator shall either issue the permit or notify the
applicant of the Administrator's determination not to issue the permit
and the reasons therefor. The applicant may correct the application or
request a waiver of the conditions for such permit within thirty days of
receipt by the applicant of such notification. The Administrator may
issue an experimental use permit only if the Administrator determines
that the applicant needs such permit in order to accumulate information
necessary to register a pesticide under section 3 of this Act. An
application for an experimental use permit may be filed at any time.
(b) Temporary Tolerance Level.--If the Administrator determines that the use of a
pesticide may reasonably be expected to result in any residue on or in food or feed,
the Administrator may establish a temporary tolerance level for the residue of the
pesticide before issuing the experimental use permit.
(c) Use under Permit.--Use of a pesticide under an experimental use permit shall
be under the supervision of the Administrator, and shall be subject to such terms
and conditions and be for such period of time as the Administrator may prescribe
in the permit.
(d) Studies.--When any experimental use permit is issued for a pesticide
containing any chemical or combination of chemicals which has not been
included in any previously registered pesticide, the Administrator may
specify that studies be conducted to detect whether the use of the
pesticide under the permit may cause unreasonable adverse effects on the
environment. All results of such studies shall be reported to the
Administrator before such pesticide may be registered under section 3.
(e) Revocation.--The Administrator may revoke any experimental use permit, at
any time, if the Administrator finds that its terms or conditions are being
violated, or that its terms and conditions are inadequate to avoid
unreasonable adverse effects on the environment.
(f) State Issuance of Permits.--Notwithstanding the foregoing provisions of this
section, the Administrator shall, under such terms and conditions as the
Administrator may by regulations prescribe, authorize any State to issue
an experimental use permit for a pesticide. All provisions of section
11 relating to State plans shall apply with equal force to a State plan for
the issuance of experimental use permits under this section.
(g) Exemption for Agricultural Research Agencies.--Notwithstanding the foregoing
provisions of this section, the Administrator may issue an experimental use permit for
a pesticide to any public or private agricultural research agency or educational
institution which applies for such permit. Each permit shall not exceed
more than a one-year period or such other specific time as the
Administrator may prescribe. Such permit shall be issued under such
terms and conditions restricting the use of the pesticide as the
Administrator may require. Such pesticide may be used only by such
research agency or educational institution for purposes of experimentation.

Sec. 6. [136d] Administrative Review; Suspension.
(a) Existing Stocks and Information.-- /1/
(1) Existing Stocks.--The Administrator may permit the continued sale and use of
existing stocks of a pesticide whose registration is suspended or canceled under this
section, or section 3 or 4, to such extent, under such conditions, and for such uses
as the Administrator determines that such sale or use is not inconsistent with the
purposes of this Act.
(2) Information.--If at any time after the registration of a pesticide the
registrant has additional factual information regarding unreasonable adverse effects
on the environment of the pesticide, the registrant shall submit such information to the
Administrator.
-----------------------------------------------------------------------------------------
/1/ Sec. 106(a)(1) of P.L. 104-170 amended subsec. (a) by striking the heading and
inserting "(a) Existing Stocks and Information.--". The second subsec. designation for
"(a)" was omitted to effectuate the probable intent of Congress.
-----------------------------------------------------------------------------------------
(b) Cancellation and Change in Classification.--If it appears to the Administrator that
a pesticide or its labeling or other material required to be submitted does not comply
with the provisions of this Act or, when used in accordance with widespread and commonly
recognized practice, generally causes unreasonable adverse effects on the environment,
the Administrator may issue a notice of the Administrator's intent either--
(1) to cancel its registration or to change its classification
together with the reasons (including the factual basis) for the
Administrator's action, or
(2) to hold a hearing to determine whether or not its
registration should be canceled or its classification changed.
Such notice shall be sent to the registrant and made public. In
determining whether to issue any such notice, the Administrator shall
include among those factors to be taken into account the impact of the
action proposed in such notice on production and prices of agricultural
commodities, retail food prices, and otherwise on the agricultural
economy. At least 60 days prior to sending such notice to the registrant
or making public such notice, whichever occurs first, the Administrator
shall provide the Secretary of Agriculture with a copy of such notice
and an analysis of such impact on the agricultural economy. If the
Secretary comments in writing to the Administrator regarding the notice
and analysis within 30 days after receiving them, the Administrator
shall publish in the Federal Register (with the notice) the comments of
the Secretary and the response of the Administrator with regard to the
Secretary's comments. If the Secretary does not comment in writing to
the Administrator regarding the notice and analysis within 30 days after
receiving them, the Administrator may notify the registrant and make
public the notice at any time after such 30-day period notwithstanding
the foregoing 60-day time requirement. The time requirements imposed by
the preceding 3 sentences may be waived or modified to the extent agreed
upon by the Administrator and the Secretary. Notwithstanding any other
provision of this subsection (b) and section 25(d), in the
event that the Administrator determines that suspension of a pesticide
registration is necessary to prevent an imminent hazard to human health,
then upon such a finding the Administrator may waive the requirement of
notice to and consultation with the Secretary of Agriculture pursuant to
subsection (b) and of submission to the Scientific Advisory Panel
pursuant to section 25(d) and proceed in accordance with subsection (c).
The proposed action shall become final and effective at the end of 30 days
from receipt by the registrant, or publication, of a notice issued under
paragraph (1), whichever occurs later, unless within that time either
(i) the registrant makes the necessary corrections, if possible, or (ii)
a request for a hearing is made by a person adversely affected by the notice.
In the event a hearing is held pursuant to such a request or to the Administrator's
determination under paragraph (2), a decision pertaining to registration
or classification issued after completion of such hearing shall be
final. In taking any final action under this subsection, the
Administrator shall consider restricting a pesticide's use or uses as an
alternative to cancellation and shall fully explain the reasons for
these restrictions, and shall include among those factors to be taken
into account the impact of such final action on production and prices of
agricultural commodities, retail food prices, and otherwise on the
agricultural economy, and the Administrator shall publish in the Federal
Register an analysis of such impact.
(c) Suspension.--
(1) Order.--If the Administrator determines that action is necessary to
prevent an imminent hazard during the time required for cancellation
or change in classification proceedings, the Administrator may, by
order, suspend the registration of the pesticide immediately. Except as provided
in paragraph (3), no order of suspension may be issued unless the Administrator
has issued, or at the same time issues, a notice of intention to cancel the
registration or change the classification of the pesticide under subsection (b).
Except as provided in paragraph (3), the Administrator shall notify the registrant
prior to issuing any suspension order. Such notice shall include findings pertaining to
the question of "imminent hazard". The registrant shall then have an opportunity,
in accordance with the provisions of paragraph (2), for an expedited hearing before the
Administrator on the question of whether an imminent hazard exists.
(2) Expedite Hearing.--If no request for a hearing is submitted to the
Administrator within five days of the registrant's receipt of the notification
provided for by paragraph (1), the suspension order may be issued
and shall take effect and shall not be reviewable by a court. If a
hearing is requested, it shall commence within five days of the
receipt of the request for such hearing unless the registrant and
the Administrator agree that it shall commence at a later time. The
hearing shall be held in accordance with the provisions of
subchapter II of of title 5 of the United States Code, except that the presiding
officer need not be a certified hearing examiner. The presiding officer shall
have ten days from the conclusion of the presentation of evidence to submit
recommended findings and conclusions to the Administrator, who shall then
have seven days to render a final order on the issue of suspension.
(3) Emergency Order.--Whenever the Administrator determines that an emergency
exists that does not permit the Administrator to hold a hearing before suspending,
the Administrator may issue a suspension order in advance of notification to the
registrant. The Administrator may issue an emergency order under this paragraph
before issuing a notice of intention to cancel the registration or change the
classification of the pesticide under subsection (b) and the Administrator
shall proceed to issue the notice under subsection (b) within 90 days of
issuing an emergency order. If the Administrator does not issue a notice
under subsection (b) within 90 days of issuing an emergency order, the emergency
order shall expire. In the case of an emergency order, paragraph (2) shall
apply except that (A) the order of the suspension shall be in effect pending the
expeditious completion of the remedies provided by that paragraph and the
issuance of a final order on suspension, and (B) no party other than the
registrant and the Administrator shall participate except that any person
adversely affected may file briefs within the time allotted by the Administrator's
rules. Any person so filing briefs shall be considered a party to such proceeding
for the purposes of section 16(b).
(4) Judicial Review.--A final order on the question of suspension following a hearing
shall be reviewable in accordance with Section 16 of this Act, notwithstanding the fact
that any related cancellation proceedings have not been completed. Any order of suspension
entered prior to a hearing before the Administrator shall be subject to immediate
review in an action by the registrant or other interested person with the concurrence of
the registrant in an appropriate district court, solely to determine whether the order of
suspension was arbitrary, capricious or an abuse of discretion, or whether the order was
issued in accordance with the procedures established by law. The effect of any order of
the court will be only to stay the effectiveness of the suspension order, pending the
Administrator's final decision with respect to cancellation or change in classification.
This action may be maintained simultaneously with any administrative review proceedings
under this section. The commencement of proceedings under this paragraph shall not operate
as a stay of order, unless ordered by the court.
(d) Public Hearings and Scientific Review.--In the event a hearing is requested pursuant
to subsection (b) or determined upon by the Administrator pursuant to subsection (b), such
hearing shall be held after due notice for the purpose of receiving evidence relevant and
material to the issues raised by the objections filed by the applicant or other interested
parties, or to the issues stated by the Administrator, if the hearing is called by the
Administrator rather than by the filing of objections. Upon a showing of relevance and
reasonable scope of evidence sought by any party to a public hearing, the Hearing Examiner
shall issue a subpena to compel testimony or production of documents from any person. The
Hearing Examiner shall be guided by the principles of the Federal Rules of Civil Procedure
in making any order for the protection of the witness or the content of documents produced
and shall order the payment of reasonable fees and expenses as a condition to requiring
testimony of the witness. On contest, the subpena may be enforced by an appropriate United
States district court in accordance with the principles stated herein. Upon the request of
any party to a public hearing and when in the Hearing Examiner's judgment it is necessary
or desirable, the Hearing Examiner shall at any time before the hearing record is closed
refer to a Committee of the National Academy of Sciences the relevant questions of
scientific fact involved in the public hearing. No member of any committee of the National
Academy of Sciences established to carry out the functions of this section shall have a
financial or other conflict of interest with respect to any matter considered by such
committee. The Committee of the National Academy of Sciences shall report in writing to
the Hearing Examiner within 60 days after such referral on these questions of scientific
fact. The report shall be made public and shall be considered as part of the hearing
record. The Administrator shall enter into appropriate arrangements with the National
Academy of Sciences to assure an objective and competent scientific review of the
questions presented to Committees of the Academy and to provide such other scientific
advisory services as may be required by the Administrator for carrying out the purposes of
this Act. As soon as practicable after completion of the hearing (including the report of
the Academy) but not later than 90 days thereafter, the Administrator shall evaluate the
data and reports before the Administrator and issue an order either revoking the
Administrator's notice of intention issued pursuant to this section, or shall issue an
order either canceling the registration, changing the classification, denying the
registration, or requiring modification of the labeling or packaging of the article.
Such order shall be based only on substantial evidence of record of such hearing and shall
set forth detailed findings of fact upon which the order is based.
(e) Conditional Registration.--
(1) The Administrator shall issue a notice of intent to cancel a
registration issued under section 3(c)(7) if (A) the
Administrator, at any time during the period provided for satisfaction
of any condition imposed, determines that the registrant has failed to
initiate and pursue appropriate action toward fulfilling any condition
imposed, or (B) at the end of the period provided for satisfaction of
any condition imposed, that condition has not been met. The
Administrator may permit the continued sale and use of existing stocks
of a pesticide whose conditional registration has been canceled under
this subsection to such extent, under such conditions, and for such uses
as the Administrator may specify if the Administrator determines that
such sale or use is not inconsistent with the purposes of this
Act and will not have unreasonable adverse effects on the
environment.
(2) A cancellation proposed under this subsection shall become final
and effective at the end of thirty days from receipt by the registrant
of the notice of intent to cancel unless during that time a request for
hearing is made by a person adversely affected by the notice. If a
hearing is requested, a hearing shall be conducted under subsection (d)
of this section. The only matters for resolution at that hearing shall
be whether the registrant has initiated and pursued appropriate action
to comply with the condition or conditions within the time provided or
whether the condition or conditions have been satisfied within the time
provided, and whether the Administrator's determination with respect to
the disposition of existing stocks is consistent with this Act. A
decision after completion of such hearing shall be final.
Notwithstanding any other provision of this section, a hearing shall be
held and a determination made within seventy-five days after receipt of
a request for such hearing.
(f) General Provisions.--
(1) Voluntary Cancellation.--
(A) A registrant may, at any time, request that a pesticide
registration of the registrant be canceled or amended to terminate
one or more pesticide uses.
(B) Before acting on a request under subparagraph (A), the
Administrator shall publish in the Federal Register a notice of the
receipt of the request and provide for a 30-day period in which the
public may comment.
(C) In the case of a pesticide that is registered for a minor
agricultural use, if the Administrator determines that the
cancellation or termination of uses would adversely affect the
availability of the pesticide for use, the Administrator--
(i) shall publish in the Federal Register a notice of the
receipt of the request and make reasonable efforts to inform
persons who so use the pesticide of the request; and
(ii) may not approve or reject the request until the
termination of the 90-day period beginning on the date of
publication of the notice in the Federal Register, except that
the Administrator may waive the 90-day period upon the request
of the registrant or if the Administrator determines that the
continued use of the pesticide would pose an unreasonable
adverse effect on the environment.
(D) Subject to paragraph (3)(B), after complying with this
paragraph, the Administrator may approve or deny the request.
(2) Publication of Notice.--A notice of denial of registration, intent to cancel,
suspension, or intent to suspend issued under this Act or a
notice issued under subsection (c)(4) or (d)(5)(A) of section 4 shall be
published in the Federal Register and shall be sent by certified mail, return
receipt requested, to the registrant's or applicant's address of record on file
with the Administrator. If the mailed notice is returned to the Administrator
as undeliverable at that address, if delivery is refused, or if the
Administrator otherwise is unable to accomplish delivery of the
notice to the registrant or applicant after making reasonable
efforts to do so, the notice shall be deemed to have been received
by the registrant or applicant on the date the notice was published
in the Federal Register.
(3) Transfer of Registration of Pesticides Registered for Minor Agricultural Uses.--
In the case of a pesticide that is registered for a minor agricultural use:
(A) During the 180-day period referred to in paragraph
(1)(C)(ii), the registrant of the pesticide may notify the
Administrator of an agreement between the registrant and a
person or persons (including persons who so use the pesticide)
to transfer the registration of the pesticide, in lieu of
canceling or amending the registration to terminate the use.
(B) An application for transfer of registration, in
conformance with any regulations the Administrator may adopt
with respect to the transfer of the pesticide registrations,
must be submitted to the Administrator within 30 days of the
date of notification provided pursuant to subparagraph (A). If
such an application is submitted, the Administrator shall
approve the transfer and shall not approve the request for
voluntary cancellation or amendment to terminate use unless the
Administrator determines that the continued use of the pesticide
would cause an unreasonable adverse effect on the environment.
(C) If the Administrator approves the transfer and the
registrant transfers the registration of the pesticide, the
Administrator shall not cancel or amend the registration to
delete the use or rescind the transfer of the registration,
during the 180-day period beginning on the date of the approval
of the transfer unless the Administrator determines that the
continued use of the pesticide would cause an unreasonable
adverse effect on the environment.
(D) The new registrant of the pesticide shall assume the
outstanding data and other requirements for the pesticide that
are pending at the time of the transfer.
(4) Utilization of data for Voluntarily Canceled Pesticide.--When an
application is filed with the Administrator for the registration of a
pesticide for a minor use and another registrant subsequently voluntarily
cancels its registration for an identical or substantially similar pesticide
for an identical or substantially similar use, the Administrator shall process,
review, and evaluate the pending application as if the voluntary cancellation had
not yet taken place except that the Administrator shall not take such action if
the Administrator determines that such minor use may cause an unreasonable adverse
effect on the environment. In order to rely on this subsection, the applicant must
certify that it agrees to satisfy any outstanding data requirements necessary to
support the reregistration of the pesticide in accordance with the data submission
schedule established by the Administrator.
(g) Notice for Stored Pesticides with Canceled or Suspended Registrations.--
(1) In General.--Any producer or exporter of pesticides, registrant of a
pesticide, applicant for registration of a pesticide, applicant for
or holder of an experimental use permit, commercial applicator, or
any person who distributes or sells any pesticide, who possesses any
pesticide which has had its registration canceled or suspended under
this section shall notify the Administrator and appropriate State
and local officials of--
(A) such possession,
(B) the quantity of such pesticide such person possesses, and
(C) the place at which such pesticide is stored.
(2) Copies.--The Administrator shall transmit a copy of each notice submitted
under this subsection to the regional office of the Environmental
Protection Agency which has jurisdiction over the place of pesticide
storage identified in the notice.
(h) Judicial Review.--Final orders of the Administrator under this section shall be
subject to judicial review pursuant to section 16.

Sec. 7. [136e] Registration of Establishments.
(a) Requirement.--No person shall produce any pesticide subject to this Act
or active ingredient used in producing a pesticide subject to this
Act in any State unless the establishment in which it is produced
is registered with the Administrator. The application for registration
of any establishment shall include the name and address of the
establishment and of the producer who operates such establishment.
(b) Registration.--Whenever the Administrator receives an application under
subsection (a), the Administrator shall register the establishment
and assign it an establishment number.
(c) Information Required.--
(1) Any producer operating an establishment registered under
this section shall inform the Administrator within 30 days after it
is registered of the types and amounts of pesticides and, if
applicable, active ingredients used in producing pesticides--
(A) which the producer is currently producing;
(B) which the producer has produced during the past year; and
(C) which the producer has sold or distributed during the
past year.
The information required by this paragraph shall be kept current and
submitted to the Administrator annually as required under such
regulations as the Administrator may prescribe.
(2) Any such producer shall, upon the request of the
Administrator for the purpose of issuing a stop sale order pursuant
to section 13, inform the Administrator of the name and address of
any recipient of any pesticide produced in any registered establishment
which the producer operates.
(d) Confidential Records and Information.--Any information submitted to the
Administrator pursuant to subsection (c) other than the names of the pesticides or
active ingredients used in producing pesticides produced, sold, or distributed at
an establishment shall be considered confidential and shall be subject to the
provisions of section 10.

Sec. 8. [136f] Books and Records.
(a) Requirements.--The Administrator may prescribe regulations requiring producers,
registrants, and applicants for registration to maintain such records
with respect to their operations and the pesticides and devices produced
as the Administrator determines are necessary for the effective
enforcement of this Act and to make the records available for
inspection and copying in the same manner as provided in subsection (b). No
records required under this subsection shall extend to financial data, sales
data other than shipment data, pricing data, personnel data, and research
data (other than data relating to registered pesticides or to a pesticide
for which an application for registration has been filed).
(b) Inspection.--For the purposes of enforcing the provisions of this Act, any
producer, distributor, carrier, dealer, or any other person who sells or
offers for sale, delivers or offers for delivery any pesticide or device
subject to this Act, shall, upon request of any officer or
employee of the Environmental Protection Agency or of any State or
political subdivision, duly designated by the Administrator, furnish or
permit such person at all reasonable times to have access to, and to
copy: (1) all records showing the delivery, movement, or holding of such
pesticide or device, including the quantity, the date of shipment and
receipt, and the name of the consignor and consignee; or (2) in the
event of the inability of any person to produce records containing such
information, all other records and information relating to such
delivery, movement, or holding of the pesticide or device. Any
inspection with respect to any records and information referred to in
this subsection shall not extend to financial data, sales data other
than shipment data, pricing data, personnel data; and research data
(other than data relating to registered pesticides or to a pesticide for
which an application for registration has been filed). Before
undertaking an inspection under this subsection, the officer or employee
must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for
distribution or sale, appropriate credentials and a written statement as
to the reason for the inspection, including a statement as to whether a
violation of the law is suspected. If no violation is suspected, an
alternate and sufficient reason shall be given in writing. Each such
inspection shall be commenced and completed with reasonable promptness.

Sec. 9. [136g] Inspection of Establishments, Etc.
(a) In General.--
(1) For purposes of enforcing the provisions of this Act,
officers or employees of the Environmental Protection Agency or of any
State duly designated by the Administrator are authorized to enter at
reasonable times (A) any establishment or other place where pesticides
or devices are held for distribution or sale for the purpose of
inspecting and obtaining samples of any pesticides or devices, packaged,
labeled, and released for shipment, and samples of any containers or
labeling for such pesticides or devices, or (B) any place where there is
being held any pesticide the registration of which has been suspended or
canceled for the purpose of determining compliance with section 19.
(2) Before undertaking such inspection, the officers or employees
must present to the owner, operator, or agent in charge of the
establishment or other place where pesticides or devices are held for
distribution or sale, appropriate credentials and a written statement as
to the reason for the inspection, including a statement as to whether a
violation of the law is suspected. If no violation is suspected, an
alternate and sufficient reason shall be given in writing. Each such
inspection shall be commenced and completed with reasonable promptness.
If the officer or employee obtains any samples, prior to leaving the
premises, the officer or employee shall give to the owner, operator, or
agent in charge a receipt describing the samples obtained and, if
requested, a portion of each such sample equal in volume or weight to
the portion retained. If an analysis is made of such samples, a copy of
the results of such analysis shall be furnished promptly to the owner,
operator, or agent in charge.
(b) Warrants.--For purposes of enforcing the provisions of this Act and
upon a showing to an officer or court of competent jurisdiction that there is
reason to believe that the provisions of this Act have been
violated, officers or employees duly designated by the Administrator are
empowered to obtain and to execute warrants authorizing--
(1) entry, inspection, and copying of records for purposes of
this section or section 8;
(2) inspection and reproduction of all records showing the
quantity, date of shipment, and the name of consignor and consignee
of any pesticide or device found in the establishment which is
adulterated, misbranded, not registered (in the case of a pesticide)
or otherwise in violation of this Act and in the event of the
inability of any person to produce records containing such
information, all other records and information relating to such
delivery, movement, or holding of the pesticide or device; and
(3) the seizure of any pesticide or device which is in violation
of this Act.
(c) Enforcement.--
(1) Certification of Facts to Attorney General.--The examination of
pesticides or devices shall be made in the Environmental Protection Agency or
elsewhere as the Administrator may designate for the purpose of determining
from such examinations whether they comply with the requirements of this Act. If it
shall appear from any such examination that they fail to comply with
the requirements of this Act, the Administrator shall cause notice to be
given to the person against whom criminal or civil proceedings are contemplated.
Any person so notified shall be given an opportunity to present the person's
views, either orally or in writing, with regard to such contemplated proceedings,
and if in the opinion of the Administrator it appears that the provisions of this
Act have been violated by such person, then the Administrator shall certify the
facts to the Attorney General, with a copy of the results of the analysis or the
examination of such pesticide for the institution of a criminal proceeding
pursuant to section 14(b) or a civil proceeding under section 14(a), when the
Administrator determines that such action will be sufficient to effectuate the
purposes of this Act.
(2) Notice Not Required.--The notice of contemplated proceedings and
opportunity to present views set forth in this subsection are not prerequisites
to the institution of any proceeding by the Attorney General.
(3) Warning Notices.--Nothing in this Act shall be construed as requiring the
Administrator to institute proceedings for prosecution of minor
violations of this Act whenever the Administrator believes
that the public interest will be adequately served by a suitable
written notice of warning.

Sec. 10. [136h] Protection of Trade Secrets and Other Information.
(a) In General.--In submitting data required by this Act, the applicant may
(1) clearly mark any portions thereof which in the applicant's opinion
are trade secrets or commercial or financial information and (2) submit
such market material separately from other material required to be
submitted under this Act.
(b) Disclosure.--Notwithstanding any other provision of this Act and subject
to the limitations in subsections (d) and (e) of this section, the
Administrator shall not make public information which in the
Administrator's judgment contains or relates to trade secrets or
commercial or financial information obtained from a person and
privileged or confidential, except that, when necessary to carry out the
provisions of this Act, information relating to formulas of
products acquired by authorization of this Act may be revealed to
any Federal agency consulted and may be revealed at a public hearing or
in findings of fact issued by the Administrator.
(c) Disputes.--If the Administrator proposes to release for inspection information
which the applicant or registrant believes to be protected from
disclosure under subsection (b), the Administrator shall
notify the applicant or registrant, in writing, by certified mail. The
Administrator shall not thereafter make available for inspection such
data until thirty days after receipt of the notice by the applicant or
registrant. During this period, the applicant or registrant may
institute an action in an appropriate district court for a declaratory
judgment as to whether such information is subject to protection under
subsection (b).
(d) Limitations.--
(1) All information concerning the objectives, methodology, results,
or significance of any test or experiment performed on or with a
registered or previously registered pesticide or its separate
ingredients, impurities, or degradation products, and any information
concerning the effects of such pesticide on any organism or the behavior
of such pesticide in the environment, including, but not limited to,
data on safety to fish and wildlife, humans and other mammals, plants,
animals, and soil, and studies on persistence, translocation and fate in
the environment, and metabolism, shall be available for disclosure to
the public. The use of such data for any registration purpose shall be
governed by section 3 of this Act. This paragraph does not
authorize the disclosure of any information that--
(A) discloses manufacturing or quality control processes,
(B) discloses the details of any methods for testing, detecting,
or measuring the quantity of any deliberately added inert ingredient
of a pesticide, or
(C) discloses the identity or percentage quantity of any
deliberately added inert ingredient of a pesticide,
unless the Administrator has first determined that disclosure is
necessary to protect against an unreasonable risk of injury to health or
the environment.
(2) Information concerning production, distribution, sale, or
inventories of a pesticide that is otherwise entitled to confidential
treatment under subsection (b) of this section may be publicly disclosed
in connection with a public proceeding to determine whether a pesticide,
or any ingredient of a pesticide, causes unreasonable adverse effects on
health or the environment, if the Administrator determines that such
disclosure is necessary in the public interest.
(3) If the Administrator proposes to disclose information described
in clause (A), (B), or (C) of paragraph (1) or in paragraph (2) of this
subsection, the Administrator shall notify by certified mail the
submitter of such information of the intent to release such information.
The Administrator may not release such information, without the
submitter's consent, until thirty days after the submitter has been
furnished such notice. Where the Administrator finds that disclosure of
information described in clause (A), (B), or (C) of paragraph (1) of
this subsection is necessary to avoid or lessen an imminent and
substantial risk of injury to the public health, the Administrator may
set such shorter period of notice (but not less than ten days) and such
method of notice as the Administrator finds appropriate. During such
period the data submitter may institute an action in an appropriate
district court to enjoin or limit the proposed disclosure. The court may
enjoin disclosure, or limit the disclosure or the parties to whom
disclosure shall be made, to the extent that--
(A) in the case of information described in clause (A), (B), or
(C) of paragraph (1) of this subsection, the proposed disclosure is
not required to protect against an unreasonable risk of injury to
health or the environment; or
(B) in the case of information described in paragraph (2) of
this subsection, the public interest in availability of the
information in the public proceeding does not outweigh the interests
in preserving the confidentiality of the information.
(e) Disclosure to Contractors..--Information otherwise protected from disclosure
to the public under subsection (b) of this section may be disclosed to contractors
with the United States and employees of such contractors if, in the opinion of
the Administrator, such disclosure is necessary for the satisfactory
performance by the contractor of a contract with the United States for
the performance of work in connection with this Act and under
such conditions as the Administrator may specify. The Administrator
shall require as a condition to the disclosure of information under this
subsection that the person receiving it take such security precautions
respecting the information as the Administrator shall by regulation
prescribe.
(f) Penalty for Disclosure by Federal Employees.--
(1) Any officer or employee of the United States or former officer
or employee of the United States who, by virtue of such employment or
official position, has obtained possession of, or has access to,
material the disclosure of which is prohibited by subsection (b) of this
section, and who, knowing that disclosure of such material is prohibited
by such subsection, willfully discloses the material in any manner to
any person not entitled to receive it, shall be fined not more than
$10,000 or imprisoned for not more than one year, or both. Section 1905
of title 18 of the United States Code shall not apply with respect to the
publishing, divulging, disclosure, or making known of, or making available,
information reported or otherwise obtained under this Act. Nothing in
this Act shall preempt any civil remedy under State or Federal law for
wrongful disclosure of trade secrets.
(2) For the purposes of this section, any contractor with the United
States who is furnished information as authorized by subsection (e) of
this section, or any employee of any such contractor, shall be
considered to be an employee of the United States.
(g) Disclosure to Foreign and Multinational Pesticide Producers.--
(1) The Administrator shall not knowingly disclose information
submitted by an applicant or registrant under this Act to any
employee or agent of any business or other entity engaged in the
production, sale, or distribution of pesticides in countries other than
the United States or in addition to the United States or to any other
person who intends to deliver such data to such foreign or multinational
business or entity unless the applicant or registrant has consented to
such disclosure. The Administrator shall require an affirmation from any
person who intends to inspect data that such person does not seek access
to the data for purposes of delivering it or offering it for sale to any
such business or entity or its agents or employees and will not
purposefully deliver or negligently cause the data to be delivered to
such business or entity or its agents or employees. Notwithstanding any
other provision of this subsection, the Administrator may disclose
information to any person in connection with a public proceeding under
law or regulation, subject to restrictions on the availability of
information contained elsewhere in this Act, which information is
relevant to a determination by the Administrator with respect to whether
a pesticide, or any ingredient of a pesticide, causes unreasonable
adverse effects on health or the environment.
(2) The Administrator shall maintain records of the names of persons
to whom data are disclosed under this subsection and the persons or
organizations they represent and shall inform the applicant or
registrant of the names and affiliations of such persons.
(3) Section 1001 of title 18 of the United States Code shall apply to
any affirmation made under paragraph (1) of this subsection.

Sec. 11. [136i] Use of Restricted Use Pesticides; Applicators.
(a) Certification Procedure.--
(1) Federal Certification.--In any State for which a State plan for applicator
certification has not been approved by the Administrator, the Administrator, in
consultation with the Governor of such State, shall conduct a
program for the certification of applicators of pesticides. Such
program shall conform to the requirements imposed upon the States
under the provisions of subsection (a)(2) of this section and shall
not require private applicators to take any examination to establish
competency in the use of pesticides. Prior to the implementation of
the program, the Administrator shall publish in the Federal Register
for review and comment a summary of the Federal plan for applicator
certification and shall make generally available within the State
copies of the plan. The Administrator shall hold public hearings at
one or more locations within the State if so requested by the
Governor of such State during the thirty days following publication
of the Federal Register notice inviting comment on the Federal plan.
The hearings shall be held within thirty days following receipt of
the request from the Governor. In any State in which the
Administrator conducts a certification program, the Administrator
may require any person engaging in the commercial application, sale,
offering for sale, holding for sale, or distribution of any
pesticide one or more uses of which have been classified for
restricted use to maintain such records and submit such reports
concerning the commercial application, sale, or distribution of such
pesticide as the Administrator may by regulation prescribe. Subject
to paragraph (2), the Administrator shall prescribe standards for
the certification of applicators of pesticides. Such standards shall
provide that to be certified, an individual must be determined to be
competent with respect to the use and handling of the pesticides, or
to the use and handling of the pesticide or class of pesticides
covered by such individual's certification. The certification
standard for a private applicator shall, under a State plan
submitted for approval, be deemed fulfilled by the applicator
completing a certification form. The Administrator shall further
assure that such form contains adequate information and affirmations
to carry out the intent of this Act, and may include in the
form an affirmation that the private applicator has completed a
training program approved by the Administrator so long as the
program does not require the private applicator to take, pursuant to
a requirement prescribed by the Administrator, any examination to
establish competency in the use of the pesticide. The Administrator
may require any pesticide dealer participating in a certification
program to be licensed under a State licensing program approved by
the Administrator.
(2) State Certification.--If any State, at any time, desires to certify
applicators of pesticides, the Governor of such State shall submit a State
plan for such purpose. The Administrator shall approve the plan submitted by
any State, or any modification thereof, if such plan in the Administrator's judgment--
(A) designates a State agency as the agency responsible for
administering the plan throughout the State;
(B) contains satisfactory assurances that such agency has or
will have the legal authority and qualified personnel necessary
to carry out the plan;
(C) gives satisfactory assurances that the State will devote
adequate funds to the administration of the plan;
(D) provides that the State agency will make such reports to
the Administrator in such form and containing such information
as the Administrator may from time to time require; and
(E) contains satisfactory assurances that State standards
for the certification of applicators of pesticides conform with
those standards prescribed by the Administrator under paragraph
(1).
Any State certification program under this section shall be
maintained in accordance with the State plan approved under this
section.
(b) State Plans.--If the Administrator rejects a plan submitted under
subsection (a)(2), the Administrator shall afford the State
submitting the plan due notice and opportunity for hearing before so
doing. If the Administrator approves a plan submitted under subsection
(a)(2), then such State shall certify applicators of pesticides with
respect to such State. Whenever the Administrator determines that a
State is not administering the certification program in accordance with
the plan approved under this section, the Administrator shall so notify
the State and provide for a hearing at the request of the State, and,
if appropriate corrective action is not taken within a reasonable time,
not to exceed ninety days, the Administrator shall withdraw approval of such plan.
(c) Instruction in Integrated Pest Management Techniques.--Standards prescribed by
the Administrator for the certification of applicators of pesticides under subsection
(a), and State plans submitted to the Administrator under subsection (a), shall
include provisions for making instructional materials concerning integrated pest
management techniques available to individuals at their request in accordance with
the provisions of section 23(c) of this Act, but such plans may not require that any
individual receive instruction concerning such techniques or to be shown
to be competent with respect to the use of such techniques. The
Administrator and States implementing such plans shall provide that all
interested individuals are notified on the availability of such
instructional materials.
(d) In General.--No regulations prescribed by the Administrator for carrying out the
provisions of this Act shall require any private applicator to maintain any
records or file any reports or other documents.
(e) Separate Standards.--When establishing or approving standards for licensing
or certification, the Administrator shall establish separate standards for
commercial and private applicators.

Sec. 12. [136j] Unlawful Acts.
(a) In General.--
(1) Except as provided by subsection (b) of this section, it shall be unlawful for
any person in any State to distribute or sell to any person--
(A) any pesticide that is not registered under section 3 or whose registration
has been canceled or suspended, except to the extent that distribution or sale
otherwise has been authorized by the Administrator under this Act;
(B) any registered pesticide if any claims made for it as a part of its
distribution or sale substantially differ from any claims made for it as a part of
the statement required in connection with its registration under section 3;
(C) any registered pesticide the composition of which differs at the time of its
distribution or sale from its composition as described in the statement required in
connection with its registration under section 3;
(D) any pesticide which has not been colored or discolored pursuant to the
provisions of section 25(c)(5);
(E) any pesticide which is adulterated or misbranded; or
(F) any device which is misbranded.
(2) It shall be unlawful for any person -
(A) to detach, alter, deface, or destroy, in whole or in part, any labeling
required under this Act;
(B) to refuse to -
(i) prepare, maintain, or submit any records required by or under section 5,
7, 8, 11, or 19;
(ii) submit any reports required by or under section 5,6, 7, 8, 11 or 19; or
(iii) allow any entry, inspection, copying of records, or sampling authorized
by this Act;
(C) to give a guaranty or undertaking provided for in subsection (b) which is
false in any particular, except that a person who receives and relies upon a guaranty
authorized under subsection (b) may give a guaranty to the same effect,
which guaranty shall contain, in addition to the person's own name and address, the
name and address of the person residing in the United States from whom the person
received the guaranty or undertaking;
(D) to use for the person's own advantage or to reveal, other
than to the Administrator, or officials or employees of the
Environmental Protection Agency or other Federal executive
agencies, or to the courts, or to physicians, pharmacists, and
other qualified persons, needing such information for the
performance of their duties, in accordance with such directions
as the Administrator may prescribe, any information acquired by
authority of this Act which is confidential under this Act;
(E) who is a registrant, wholesaler, dealer, retailer, or other
distributor to advertise a product registered under this
Act for restricted use without giving the classification
of the product assigned to it under section 3;
(F) to distribute or sell, or to make available for use, or to
use, any registered pesticide classified for restricted use for
some or all purposes other than in accordance with section
3(d) and any regulations thereunder, except that it shall not be unlawful
to sell, under regulations issued by the Administrator, a restricted use
pesticide to a person who is not a certified applicator for application by
a certified applicator;
(G) to use any registered pesticide in a manner inconsistent with its labeling;
(H) to use any pesticide which is under an experimental use permit contrary
to the provisions of such permit;
(I) to violate any order issued under section 13;
(J) to violate any suspension order issued under section 3(c)(2)(B), 4, or 6;
(K) to violate any cancellation order issued under this Act or to fail to
submit a notice in accordance with section 6(g);
(L) who is a producer to violate any of the provisions of section 7;
(M) to knowingly falsify all or part of any application for registration,
application for experimental use permit, any information submitted to the
Administrator pursuant to section 7, any records required to be maintained
pursuant to this Act, any report filed under this Act, or any information
marked as confidential and submitted to the Administrator under any provision
of this Act;
(N) who is a registrant, wholesaler, dealer, retailer, or other distributor
to fail to file reports required by this Act;
(O) to add any substance to, or take any substance from, any pesticide in
a manner that may defeat the purpose of this Act;
(P) to use any pesticide in tests on human beings unless such human beings
(i) are fully informed of the nature and purposes of the test and of any physical
and mental health consequences which are reasonably foreseeable therefrom, and
(ii) freely volunteer to participate in the test;
(Q) to falsify all or part of any information relating to the testing of
any pesticide (or any ingredient, metabolite, or degradation product thereof),
including the nature of any protocol, procedure, substance, organism, or equipment
used, observation made, or conclusion or opinion formed, submitted to the
Administrator, or that the person knows will be furnished to the Administrator or
will become a part of any records required to be maintained by this Act;
(R) to submit to the Administrator data known to be false in support of a
registration; or
(S) to violate any regulation issued under section 3(a) or 19.
(b) Exemptions.--The penalties provided for a violation of paragraph (1) of
subsection (a) shall not apply to--
(1) any person who establishes a guaranty signed by, and
containing the name and address of, the registrant or person
residing in the United States from whom the person purchased or
received in good faith the pesticide in the same unbroken package,
to the effect that the pesticide was lawfully registered at the time
of sale and delivery to the person, and that it complies with the
other requirements of this Act, and in such case the
guarantor shall be subject to the penalties which would otherwise
attach to the person holding the guaranty under the provisions of
this Act;
(2) any carrier while lawfully shipping, transporting, or
delivering for shipment any pesticide or device, if such carrier
upon request of any officer or employee duly designated by the
Administrator shall permit such officer or employee to copy all of
its records concerning such pesticide or device;
(3) any public official while engaged in the performance of the
official duties of the public official;
(4) any person using or possessing any pesticide as provided by
an experimental use permit in effect with respect to such pesticide
and such use or possession; or
(5) any person who ships a substance or mixture of substances
being put through tests in which the purpose is only to determine
its value for pesticide purposes or to determine its toxicity or
other properties and from which the user does not expect to receive
any benefit in pest control from its use.

Sec. 13. [136k] Stop Sale, Use, Removal, and Seizure.
(a) Stop Sale, Etc., Orders.--Whenever any pesticide or device is found by the
Administrator in any State and there is reason to believe on the basis of
inspection or tests that such pesticide or device is in violation of any of the
provisions of this Act, or that such pesticide or device has been
or is intended to be distributed or sold in violation of any such
provisions, or when the registration of the pesticide has been canceled
by a final order or has been suspended, the Administrator may issue a
written or printed "stop sale, use, or removal" order to any person
who owns, controls, or has custody of such pesticide or device, and
after receipt of such order no person shall sell, use, or remove the
pesticide or device described in the order except in accordance with the
provisions of the order.
(b) Seizure.--Any pesticide or device that is being transported or, having been
transported, remains unsold or in original unbroken packages, or that is
sold or offered for sale in any State, or that is imported from a
foreign country, shall be liable to be proceeded against in any district
court in the district where it is found and seized for confiscation by a
process in rem for condemnation if--
(1) in the case of a pesticide--
(A) it is adulterated or misbranded;
(B) it is not registered pursuant to the provisions of
section 3;
(C) its labeling fails to bear the information required by
this Act;
(D) it is not colored or discolored and such coloring or
discoloring is required under this Act; or
(E) any of the claims made for it or any of the directions
for its use differ in substance from the representations made in
connection with its registration;
(2) in the case of a device, it is misbranded; or
(3) in the case of a pesticide or device, when used in
accordance with the requirements imposed under this Act and
as directed by the labeling, it nevertheless causes unreasonable
adverse effects on the environment.
In the case of a plant regulator, defoliant, or desiccant, used in
accordance with the label claims and recommendations, physical or
physiological effects on plants or parts thereof shall not be deemed to
be injury, when such effects are the purpose for which the plant
regulator, defoliant, or desiccant was applied.
(c) Disposition after Condemnation.--If the pesticide or device is condemned it shall,
after entry of the decree, be disposed of by destruction or sale as the court may
direct and the proceeds, if sold, less the court costs, shall be paid into the
Treasury of the United States, but the pesticide or device shall not be
sold contrary to the provisions of this Act or the laws of the
jurisdiction in which it is sold. On payment of the costs of the
condemnation proceedings and the execution and delivery of a good and
sufficient bond conditioned that the pesticide or device shall not be
sold or otherwise disposed of contrary to the provisions of the
Act or the laws of any jurisdiction in which sold, the court may
direct that such pesticide or device be delivered to the owner thereof.
The proceedings of such condemnation cases shall conform, as near as may
be to the proceedings in admiralty, except that either party may demand
trial by jury of any issue of fact joined in any case, and all such
proceedings shall be at the suit of and in the name of the United
States.
(d) Court Costs, Etc.--When a decree of condemnation is entered against the
pesticide or device, court costs and fees, storage, and other proper expenses
shall be awarded against the person, if any, intervening as claimant of the
pesticide or device.

Sec. 14. [136l] Penalties.
(a) Civil Penalties.
(1) In General.--Any registrant, commercial applicator, wholesaler, dealer,
retailer, or other distributor who violates any provision of this
Act may be assessed a civil penalty by the Administrator of not more than
$5,000 for each offense.
(2) Private Applicator.--Any private applicator or other person not included in
paragraph (1) who violates any provision of this Act subsequent to
receiving a written warning from the Administrator or following a
citation for a prior violation, may be assessed a civil penalty by
the Administrator of not more than $1,000 for each offense, except
that any applicator not included under paragraph (1) of this
subsection who holds or applies registered pesticides, or uses
dilutions of registered pesticides, only to provide a service of
controlling pests without delivering any unapplied pesticide to any
person so served, and who violates any provision of this Act
may be assessed a civil penalty by the Administrator of not more
than $500 for the first offense nor more than $1,000 for each
subsequent offense.
(3) Hearing.--No civil penalty shall be assessed unless the person charged
shall have been given notice and opportunity for a hearing on such
charge in the county, parish, or incorporated city of the residence
of the person charged.
(4) Determination of Penalty.--In determining the amount of the penalty,
the Administrator shall consider the appropriateness of such penalty to the
size of the business of the person charged, the effect on the person's
ability to continue in business, and the gravity of the violation.
Whenever the Administrator finds that the violation occurred despite
the exercise of due care or did not cause significant harm to health
or the environment, the Administrator may issue a warning in lieu of
assessing a penalty.
(5) References to Attorney General.--In case of inability to collect such civil
penalty or failure of any person to pay all, or such portion of such civil penalty
as the Administrator may determine, the Administrator shall refer the matter to
the Attorney General, who shall recover such amount by action in the appropriate
United States district court.
(b) Criminal Penalties.--
(1) In General.--
(A) Any registrant, applicant for a registration, or producer
who knowingly violates any provision of this Act shall be
fined not more than $50,000 or imprisoned for not more than 1 year,
or both.
(B) Any commercial applicator of a restricted use pesticide, or
any other person not described in subparagraph (A) who distributes
or sells pesticides or devices, who knowingly violates any provision
of this Act shall be fined not more than $25,000 or
imprisoned for not more than 1 year, or both.
(2) Private Applicator.--Any private applicator or other person not included
in paragraph (1) who knowingly violates any provision of this Act shall be
guilty of a misdemeanor and shall on conviction be fined not more than $1,000, or
imprisoned for not more than 30 days, or both.
(3) Disclosure of Information.--Any person, who, with intent to defraud, uses
or reveals information relative to formulas of products acquired under the
authority of section 136a of this title, shall be fined not more
than $10,000, or imprisoned for not more than three years, or both.
(4) Acts of Officers, Agents, Etc.--When construing and enforcing the provisions
of this Act, the act, omission, or failure of any officer, agent, or other person
acting for or employed by any person shall in every case be also deemed to be the
act, omission, or failure of such person as well as that of the person employed.

Sec. 15. [136m] Indemnities.
(a) General Indemnification.
(1) In General.--Except as otherwise provided in this section, if--
(A) the Administrator notifies a registrant under section
6(c)(1) that the Administrator intends to suspend a registration
or that an emergency order of suspension of a registration under
section 6(c)(3) has been issued;
(B) the registration in question is suspended under section
6(c), and thereafter is canceled under section 6(b), 6(d), or 6(f); and
(C) any person who owned any quantity of the pesticide
immediately before the notice to the registrant under
subparagraph (A) suffered losses by reason of suspension or
cancellation of the registration;
the Administrator shall make an indemnity payment to the person.
(2) Exception.--Paragraph (1) shall not apply if the Administrator finds that
the person--
(A) had knowledge of facts that, in themselves, would have
shown that the pesticide did not meet the requirements of
section 3(c)(5) for registration; and
(B) continued thereafter to produce the pesticide without
giving timely notice of such facts to the Administrator.
(3) Report.--If the Administrator takes an action under paragraph (1)
that requires the payment of indemnification, the Administrator shall
report to the Committee on Agriculture of the House of Representatives,
the Committee on Agriculture, Nutrition, and Forestry of the Senate, and the
Committees on Appropriations of the House of Representatives and the Senate on--
(A) the action taken that requires the payment of indemnification;
(B) the reasons for taking the action;
(C) the estimated cost of the payment; and
(D) a request for the appropriation of funds for the payment.
(4) Appropriation.--The Administrator may not make a payment of indemnification
under paragraph (1) unless a specific line item appropriation of funds has been made
in advance for the payment.
(b) Indemnification of End Users, Dealers, and Distributors.--
(1) End Users.--If--
(A) the Administrator notifies a registrant under section
6(c)(1) that the Administrator intends to suspend a registration
or that an emergency order of suspension of a registration under
section 6(c)(3) has been issued;
(B) the registration in question is suspended under section
6(c), and thereafter is canceled under section 6(b), 6(d), or 6(f); and
(C) any person who, immediately before the notice to the
registrant under subparagraph (A), owned any quantity of the
pesticide for purposes of applying or using the pesticide as an
end user, rather than for purposes of distributing or selling it
or further processing it for distribution or sale, suffered a
loss by reason of the suspension or cancellation of the
pesticide;
the person shall be entitled to an indemnity payment under this
subsection for such quantity of the pesticide.
(2) Dealers and Distributors.--
(A) Any registrant, wholesaler, dealer, or other distributor
(hereinafter in this paragraph referred to as a "seller") of a
registered pesticide who distributes or sells the pesticide directly
to any person not described as an end user in paragraph (1)(C)
shall, with respect to any quantity of the pesticide that such
person cannot use or resell as a result of the suspension or
cancellation of the pesticide, reimburse such person for the cost of
first acquiring the pesticide from the seller (other than the cost
of transportation, if any), unless the seller provided to the person
at the time of distribution or sale a notice, in writing, that the
pesticide is not subject to reimbursement by the seller.
(B) If--
(i) the Administrator notifies a registrant under section
6(c)(1) that the Administrator intends to suspend a registration
or that an emergency order of suspension of a registration under
section 6(c)(3) has been issued;
(ii) the registration in question is suspended under section
6(c), and thereafter is canceled under section 6(b), 6(d), or 6(f);
(iii) any person who, immediately before the notice to the
registrant under clause (i)--
(I) had not been notified in writing by the seller, as
provided under subparagraph (A), that any quantity of the
pesticide owned by such person is not subject to
reimbursement by the seller in the event of suspension or
cancellation of the pesticide; and
(II) owned any quantity of the pesticide for purposes
of--
(aa) distributing or selling it; or
(bb) further processing it for distribution or sale
directly to an end user;
suffered a loss by reason of the suspension or cancellation of
the pesticide; and
(iv) the Administrator determines on the basis of a claim of
loss submitted to the Administrator by the person, that the
seller--
(I) did not provide the notice specified in subparagraph
(A) to such person; and
(II) is and will continue to be unable to provide
reimbursement to such person, as provided under subparagraph
(A), for the loss referred to in clause (iii), as a result
of the insolvency or bankruptcy of the seller and the
seller's resulting inability to provide such reimbursement;
the person shall be entitled to an indemnity payment under this
subsection for such quantity of the pesticide.
(C) If an indemnity payment is made by the United States under
this paragraph, the United States shall be subrogated to any right
that would otherwise be held under this paragraph by a seller who is
unable to make a reimbursement in accordance with this paragraph
with regard to reimbursements that otherwise would have been made by
the seller.
(3) Source.--Any payment required to be made under paragraph (1) or (2)
shall be made from the appropriation provided under section 1304 of title 31,
United States Code.
(4) Administrative Settlement.--An administrative settlement of a claim
for such indemnity may be made in accordance with the third paragraph of
section 2414 of title 28, United States Code, and shall be regarded as if it
were made under that section for purposes of section 1304 of title 31, United
States Code.
(c) Amount of Payment.--
(1) In General.--The amount of an indemnity payment under subsection (a)
or (b) of this section to any person shall be determined on the basis of
the cost of the pesticide owned by the person (other than the cost
of transportation, if any) immediately before the issuance of the
notice to the registrant referred to in subsection (a)(1)(A),
(b)(1)(A), or (b)(2)(B)(i), except that in no event shall an indemnity
payment to any person exceed the fair market value of the pesticide owned
by the person immediately before the issuance of the notice.
(2) Special Rule.--Notwithstanding any other provision of this Act, the
Administrator may provide a reasonable time for use or other
disposal of the pesticide. In determining the quantity of any
pesticide for which indemnity shall be paid under this section,
proper adjustment shall be made for any pesticide used or otherwise
disposed of by the owner.

Sec. 16. [136n] Administrative Procedure; Judicial Review.
(a) District Court Review.--Except as otherwise provided in this Act,
the refusal of the Administrator to cancel or suspend a registration or
to change a classification not following a hearing and other final actions
of the Administrator not committed to the discretion of the Administrator by
law are judicially reviewable by the district courts of the United States.
(b) Review by Court of Appeals.--In the case of actual controversy as to the
validity of any order issued by the Administrator following a public hearing,
any person who will be adversely affected by such order and who had been a party
to the proceedings may obtain judicial review by filing in the United States
court of appeals for the circuit wherein such person resides or has a
place of business, within 60 days after the entry of such order, a
petition praying that the order be set aside in whole or in part. A copy
of the petition shall be forthwith transmitted by the clerk of the court
to the Administrator or any officer designated by the Administrator for
that purpose, and thereupon the Administrator shall file in the court
the record of the proceedings on which the Administrator based the
Administrator's order, as provided in section 2112 of title 28, United States
Code. Upon the filing of such petition the court shall have exclusive jurisdiction
to affirm or set aside the order complained of in whole or in part. The
court shall consider all evidence of record. The order of the
Administrator shall be sustained if it is supported by substantial
evidence when considered on the record as a whole. The judgment of the
court affirming or setting aside, in whole or in part, any order under
this section shall be final, subject to review by the Supreme Court of
the United States upon certiorari or certification as provided in
section 1254 of title 28, United States Code. The commencement of proceedings
under this section shall not, unless specifically ordered by the court to the
contrary, operate as a stay of an order.
(c) Jurisdiction of District Courts.--The district courts of the United States
are vested with jurisdiction specifically to enforce, and to prevent and restrain
violations of, this act.
(d) Notice of Judgments.--The Administrator shall, by publication in such manner
as the Administrator may prescribe, give notice of all judgments entered in
actions instituted under the authority of this Act.

Sec. 17. [136o] Imports and Exports.
(a) Pesticides and Devices Intended for Export.--Notwithstanding any other provision
of this Act, no pesticide or device or active ingredient used in producing a pesticide
intended solely for export to any foreign country shall be deemed in violation of
this Act--
(1) when prepared or packed according to the specifications or
directions of the foreign purchaser, except that producers of such
pesticides and devices and active ingredients used in producing
pesticides shall be subject to sections 2(p), 2(q)(1)(A), (C), (D),
(E), (G), and (H), 2(q)(2)(A), (B), (C)(i) and (iii), and (D),
7, and 8 of this Act; and
(2) in the case of any pesticide other than a pesticide
registered under section 3 or sold under section 6(a)(1) of
this Act, if, prior to export, the foreign purchaser has signed a
statement acknowledging that the purchaser understands that such
pesticide is not registered for use in the United States and cannot
be sold in the United States under this Act.
A copy of that statement shall be transmitted to an appropriate official
of the government of the importing country.
(b) Cancellation Notices Furnished to Foreign Governments.--Whenever a registration,
or a cancellation or suspension of the registration of a pesticide becomes effective,
or ceases to be effective, the Administrator shall transmit through the State Department
notification thereof to the governments of other countries and to appropriate
international agencies. Such notification shall, upon request, include all information
related to the cancellation or suspension of the registration of the pesticide and
information concerning other pesticides that are registered under section 3 of
this Act and that could be used in lieu of such pesticide.
(c) Importation of Pesticides and Devices.--The Secretary of the Treasury shall
notify the Administrator of the arrival of pesticides and devices and shall deliver
to the Administrator, upon the Administrator's request, samples of pesticides
or devices which are being imported into the United States, giving
notice to the owner or consignee, who may appear before the
Administrator and have the right to introduce testimony. If it appears
from the examination of a sample that it is adulterated, or misbranded
or otherwise violated the provisions set forth in this Act, or is
otherwise injurious to health or the environment, the pesticide or
device may be refused admission, and the Secretary of the Treasury shall
refuse delivery to the consignee and shall cause the destruction of any
pesticide or device refused delivery which shall not be exported by the
consignee within 90 days from the date of notice of such refusal under
such regulations as the Secretary of the Treasury may prescribe. The
Secretary of the Treasury may deliver to the consignee such pesticide or
device pending examination and decision in the matter on execution of
bond for the amount of the full invoice value of such pesticide or
device, together with the duty thereon, and on refusal to return such
pesticide or device for any cause to the custody of the Secretary of the
Treasury, when demanded, for the purpose of excluding them from the
country, or for any other purpose, said consignee shall forfeit the full
amount of said bond. All charges for storage, cartage, and labor on
pesticides or devices which are refused admission or delivery shall be
paid by the owner or consignee, and in default of such payment shall
constitute a lien against any future importation made by such owner or
consignee.
(d) Cooperation in International Efforts.--The Administrator shall, in
cooperation with the Department of State and any other appropriate Federal
agency, participate and cooperate in any international efforts to develop
improved pesticide research and regulations.
(e) Regulations.--The Secretary of the Treasury, in consultation with the
Administrator, shall prescribe regulations for the enforcement of subsection
(c) of this section.

Sec. 18. [136p] Exemption of Federal and State Agencies.
The Administrator may, at the Administrator's discretion, exempt any
Federal or State agency from any provision of this Act if the
Administrator determines that emergency conditions exist which require
such exemption. The Administrator, in determining whether or not such
emergency conditions exist, shall consult with the Secretary of
Agriculture and the Governor of any State concerned if they request such
determination.

Sec. 19. [136q] Storage, Disposal, Transportation, and Recall.
(a) Storage, Disposal, and Transportation.--
(1) Data Requirements and Registration of Pesticides.--The Administrator may
require under section 3 or 6 that--
(A) the registrant or applicant for registration of a
pesticide submit or cite data or information regarding methods
for the safe storage and disposal of excess quantities of the
pesticide to support the registration or continued registration
of a pesticide;
(B) the labeling of a pesticide contain requirements and
procedures for the transportation, storage, and disposal of the
pesticide, any container of the pesticide, any rinsate
containing the pesticide, or any other material used to contain
or collect excess or spilled quantities of the pesticide; and
(C) the registrant of a pesticide provide evidence of
sufficient financial and other resources to carry out a recall
plan under subsection (b), and provide for the disposition of
the pesticide, in the event of suspension and cancellation of the pesticide.
(2) Pesticides.--The Administrator may by regulation, or as part of
an order issued under section 6 or an amendment to such an order--
(A) issue requirements and procedures to be followed by any
person who stores or transports a pesticide the registration of
which has been suspended or canceled;
(B) issue requirements and procedures to be followed by any
person who disposes of stocks of a pesticide the registration of
which has been suspended; and
(C) issue requirements and procedures for the disposal of
any pesticide the registration of which has been canceled.
(3) Containers, Rinsates, and Other Materials.--The Administrator may by
regulation, or as part of an order issued under section 6 or an amendment to such an
order--
(A) issue requirements and procedures to be followed by any
person who stores or transports any container of a pesticide the
registration of which has been suspended or canceled, any
rinsate containing the pesticide, or any other material used to
contain or collect excess or spilled quantities of the
pesticide;
(B) issue requirements and procedures to be followed by any
person who disposes of stocks of any container of a pesticide
the registration of which has been suspended, any rinsate
containing the pesticide, or any other material used to contain
or collect excess or spilled quantities of the pesticide; and
(C) issue requirements and procedures for the disposal of
any container of a pesticide the registration of which has been
canceled, any rinsate containing the pesticide, or any other
material used to contain or collect excess or spilled quantities
of the pesticide.
(b) Recalls.--
(1) In General.--If the registration of a pesticide has been suspended and
canceled under section 6, and if the Administrator finds that recall of the
pesticide is necessary to protect health or the environment, the Administrator
shall order a recall of the pesticide in accordance with this subsection.
(2) Voluntary Recall.--If, after determining under paragraph (1) that a
recall is necessary, the Administrator finds that voluntary recall by the
registrant and others in the chain of distribution may be as safe and effective
as a mandatory recall, the Administrator shall request the registrant of the
pesticide to submit, within 60 days of the request, a plan for the voluntary
recall of the pesticide. If such a plan is requested and submitted, the Administrator
shall approve the plan and order the registrant to conduct the recall in accordance
with the plan unless the Administrator determines, after an informal hearing, that
the plan is inadequate to protect health or the environment.
(3) Mandatory Recall.--If, after determining under paragraph (1) that a recall
is necessary, the Administrator does not request the submission of a plan under
paragraph (2) or finds such a plan to be inadequate, the Administrator shall issue a
regulation that prescribes a plan for the recall of the pesticide. A regulation issued
under this paragraph may apply to any person who is or was a registrant, distributor,
or seller of the pesticide, or any successor in interest to such a person.
(4) Recall Procedure.--A regulation issued under this subsection may require any
person that is subject to the regulation to--
(A) arrange to make available one or more storage facilities
to receive and store the pesticide to which the recall program
applies, and inform the Administrator of the location of each
such facility;
(B) accept and store at such a facility those existing
stocks of such pesticide that are tendered by any other person
who obtained the pesticide directly or indirectly from the
person that is subject to such regulation;
(C) on the request of a person making such a tender, provide
for proper transportation of the pesticide to a storage
facility; and
(D) take such reasonable steps as the regulation may
prescribe to inform persons who may be holders of the pesticide
of the terms of the recall regulation and how those persons may
tender the pesticide and arrange for transportation of the
pesticide to a storage facility.
(5) Contents of Recall Plan.--A recall plan established under this
subsection shall include--
(A) the level in the distribution chain to which the recall
is to extend, and a schedule for recall; and
(B) the means to be used to verify the effectiveness of the
recall.
(6) Requirements or Procedures.--No requirement or procedure imposed
in accordance with paragraph (2) of subsection (a) may require the recall of
existing stocks of the pesticide except as provided by this subsection.
(c) Storage Costs.--
(1) Submission of Plan.--A registrant who wishes to become eligible for
reimbursement of storage costs incurred as a result of a recall prescribed under
subsection (b) for a pesticide whose registration has been suspended and canceled
shall, as soon as practicable after the suspension of the registration of the
pesticide, submit to the Administrator a plan for the storage and disposal of the
pesticide that meets criteria established by the Administrator by regulation.
(2) Reimbursement.--Within a reasonable period of time after such storage costs
are incurred and paid by the registrant, the Administrator shall reimburse the registrant,
on request, for--
(A) none of the costs incurred by the registrant before the
date of submission of the plan referred to in paragraph (1) to
the Administrator;
(B) 100 percent of the costs incurred by the registrant
after the date of submission of the plan to the Administrator or
the date of cancellation of the registration of the pesticide,
whichever is later, but before the approval of the plan by the
Administrator;
(C) 50 percent of the costs incurred by the registrant
during the 1-year period beginning on the date of the approval
of the plan by the Administrator or the date of cancellation of
the registration of the pesticide, whichever is later;
(D) none of the costs incurred by the registrant during the
3-year period beginning on the 366th day following approval of
the plan by the Administrator or the date of cancellation of the
registration of the pesticide, whichever is later; and
(E) 25 percent of the costs incurred by the registrant
during the period beginning on the first day of the 5th year
following the date of the approval of the plan by the
Administrator or the date of cancellation of the registration of
the pesticide, whichever is later, and ending on the date that a
disposal permit for the pesticide is issued by a State or an
alternative plan for disposal of the pesticide in accordance
with applicable law has been developed.
(d) Administration of Storage, Disposal, Transportation, and Recall Programs.--
(1) Voluntary Agreements.--Nothing in this section shall be construed as
preventing or making unlawful any agreement between a seller and a buyer of any
pesticide or other substance regarding the ultimate allocation of the costs of
storage, transportation, or disposal of a pesticide.
(2) Rule and Regulation Review.--Section 25(a)(4) shall not apply to any
regulation issued under subsection (a)(2) or (b).
(3) Limitations.--No registrant shall be responsible under this section for
a pesticide the registration of which is held by another person. No distributor
or seller shall be responsible under this section for a pesticide that the
distributor or seller did not hold or sell.
(4) Seizure and Penalties.--If the Administrator finds that a person who is
subject to a regulation or order under subsection (a)(2) or (b) has failed
substantially to comply with that regulation or order, the Administrator may take
action under section 13 or 14 or obtain injunctive relief under section 16(c)
against such person or any successor in interest of any such person.
(e) Container Design.--
(1) Procedures.--
(A) Not later than 3 years after the effective date of this
subsection, the Administrator shall, in consultation with the heads
of other interested Federal agencies, promulgate regulations for the
design of pesticide containers that will promote the safe storage
and disposal of pesticides.
(B) The regulations shall ensure, to the fullest extent
practicable, that the containers--
(i) accommodate procedures used for the removal of
pesticides from the containers and the rinsing of the
containers;
(ii) facilitate the safe use of the containers, including
elimination of splash and leakage of pesticides from the
containers;
(iii) facilitate the safe disposal of the containers; and
(iv) facilitate the safe refill and reuse of the containers.
(2) Compliance.--The Administrator shall require compliance with the regulations
referred to in paragraph (1) not later than 5 years after the effective date of this
subsection.
(f) Pesticide Residue Removal.--
(1) Procedures.-
(A) Not later than 3 years after the effective date of this
subsection, the Administrator shall, in consultation with the heads
of other interested Federal agencies, promulgate regulations
prescribing procedures and standards for the removal of pesticides
from containers prior to disposal.
(B) The regulations may--
(i) specify, for each major type of pesticide container,
procedures and standards providing for, at a minimum, triple
rinsing or the equivalent degree of pesticide removal;
(ii) specify procedures that can be implemented promptly and
easily in various circumstances and conditions;
(iii) provide for reuse, whenever practicable, or disposal
of rinse water and residue; and
(iv) be coordinated with requirements for the rinsing of
containers imposed under the Solid Waste Disposal Act (42 U.S.C.
6901 et seq.).
(C) The Administrator may, at the discretion of the
Administrator, exempt products intended solely for household use
from the requirements of this subsection.
(2) Compliance.--Effective beginning 5 years after the effective date of
this subsection, a State may not exercise primary enforcement responsibility
under section 11, unless the Administrator determines that the State is carrying
out an adequate program to ensure compliance with this subsection.
(3) Solid Waste Disposal Act.--Nothing in this subsection shall affect the
authorities or requirements concerning pesticide containers under the Solid Waste
Disposal Act (42 U.S.C. 6901).
(g) Pesticide Container Study.--
(1) Study.--
(A) The Administrator shall conduct a study of options to
encourage or require--
(i) the return, refill, and reuse of pesticide containers;
(ii) the development and use of pesticide formulations that
facilitate the removal of pesticide residues from containers;
and
(iii) the use of bulk storage facilities to reduce the
number of pesticide containers requiring disposal.
(B) In conducting the study, the Administrator shall--
(i) consult with the heads of other interested Federal
agencies, State agencies, industry groups, and environmental
organizations; and
(ii) assess the feasibility, costs, and environmental
benefits of encouraging or requiring various measures or
actions.
(2) Report.--Not later than 2 years after the effective date of this
subsection, the Administrator shall submit to Congress a report
describing the results of the study required under paragraph (1).
(h) Relationship to Solid Waste Disposal Act.--
(1) In General.--Nothing in this section shall diminish the authorities
or requirements of the Solid Waste Disposal Act (42 U.S.C. 6901 et seq.).
(2) Antimicrobial Products.--A household, industrial, or institutional
antimicrobial product that is not subject to regulation under the Solid
Waste Disposal Act (42 U.S.C. 6901 et seq.) shall not be subject to the
provisions of subsections (a), (e), and (f), unless the Administrator
determines that such product must be subject to such provisions to prevent
an unreasonable adverse effect in the environment.

Sec. 20. [136r] Research and Monitoring
(a) Research.--The Administrator shall undertake research including research by
grant or contract with other Federal agencies, universities, or others
as may be necessary to carry out the purposes of this Act, and
the Administrator shall conduct research into integrated pest management
in coordination with the Secretary of Agriculture. The Administrator
shall also take care to ensure that such research does not duplicate
research being undertaken by any other Federal agency.
(b) National Monitoring Plan.--The Administrator shall formulate and periodically
revise, in cooperation with other Federal, State, or local agencies, a national
plan for monitoring pesticides.
(c) Monitoring.--The Administrator shall undertake such monitoring activities,
including, but not limited to monitoring in air, soil, water, man,
plants, and animals, as may be necessary for the implementation of this
Act and of the national pesticide monitoring plan. The
Administrator shall establish procedures for the monitoring of man and
animals and their environment for incidental pesticide exposure,
including, but not limited to, the quantification of incidental human
and environmental pesticide pollution and the secular trends thereof,
and identification of the sources of contamination and their
relationship to human and environmental effects. Such activities shall
be carried out in cooperation with other Federal, State, and local
agencies.

Sec. 21. [136s] Solicitation of comments; Notice of Public Hearings.
(a) Secretary of Agriculture.--The Administrator, before publishing regulations under
this Act, shall solicit the views of the Secretary of Agriculture in
accordance with the procedure described in section 25(a).
(b) Secretary of Health and Human Services.--The Administrator, before publishing
regulations under this Act for any public health pesticide, shall solicit the
views of the Secretary of Health and Human Services in the same manner as the
views of the Secretary of Agriculture are solicited under section 25(a)(2).
(c) Views.--In addition to any other authority relating to public hearings and
solicitation of views, in connection with the suspension or cancellation
of a pesticide registration or any other actions authorized under this
Act, the Administrator may, at the Administrator's discretion,
solicit the views of all interested persons, either orally or in
writing, and seek such advice from scientists, farmers, farm
organizations, and other qualified persons as the Administrator deems
proper.
(d) Notice.--In connection with all public hearings under this Act the
Administrator shall publish timely notice of such hearings in the
Federal Register.

Sec. 22. [136t] Delegation and Cooperation.
(a) Delegation.--All authority vested in the Administrator by virtue of the
provisions of this Act may with like force and effect be executed
by such employees of the Environmental Protection Agency as the
Administrator may designate for the purpose.
(b) Cooperation.--The Administrator shall cooperate with Department of Agriculture,
any other Federal agency, and any appropriate agency of any State or any
political subdivision thereof, in carrying out the provisions of this
Act, and in securing uniformity of regulations.

Sec. 23. [136u] State Cooperation, Aid, and Training.
(a) Cooperative Agreements.--The Administrator may enter into cooperative agreements
with States and Indian tribes--
(1) to delegate to any State or Indian tribe the authority to
cooperate in the enforcement of this Act through the use of
its personnel or facilities, to train personnel of the State or
Indian tribe to cooperate in the enforcement of this Act, and
to assist States and Indian tribes in implementing cooperative
enforcement programs through grants-in-aid; and
(2) to assist States in developing and administering State
programs, and Indian tribes that enter into cooperative agreements,
to train and certify applicators consistent with the standards the
Administrator prescribes.
Effective with the fiscal year beginning October 1, 1978, there are
authorized to be appropriated annually such funds as may be necessary
for the Administrator to provide through cooperative agreements an
amount equal to 50 percent of the anticipated cost to each State or
Indian tribe, as agreed to under such cooperative agreements, of
conducting training and certification programs during such fiscal year.
If funds sufficient to pay 50 percent of the costs for any year are not
appropriated, the share of each State and Indian tribe shall be reduced
in a like proportion in allocating available funds.
(b) Contracts for Training.--In addition, the Administrator may enter into
contracts with Federal, State, or Indian tribal agencies for the purpose of
encouraging the training of certified applicators.
(c) Information and Education.--The Administrator shall, in cooperation with
the Secretary of Agriculture, use the services of the cooperative State extension
services to inform and educate pesticide users about accepted uses and other
regulations made under this Act.

Sec. 24. [136v] Authority of States.
(a) In General.--A State may regulate the sale or use of any federally
registered pesticide or device in the State, but only if and to the extent
the regulation does not permit any sale or use prohibited by this Act.
(b) Uniformity.--Such State shall not impose or continue in effect any
requirements for labeling or packaging in addition to or different from
those required under this Act.
(c) Additional Uses.--
(1) A State may provide registration for additional uses of
federally registered pesticides formulated for distribution and use
within that State to meet special local needs in accord with the
purposes of this Act and if registration for such use has not
previously been denied, disapproved, or canceled by the Administrator.
Such registration shall be deemed registration under section 3 for
all purposes of this Act, but shall authorize distribution and use
only within such State.
(2) A registration issued by a State under this subsection shall not
be effective for more than ninety days if disapproved by the
Administrator within that period. Prior to disapproval, the
Administrator shall, except as provided in paragraph (3) of this
subsection, advise the State of the Administrator's intention to
disapprove and the reasons therefor, and provide the State time to
respond. The Administrator shall not prohibit or disapprove a
registration issued by a State under this subsection (A) on the basis of
lack of essentiality of a pesticide or (B) except as provided in
paragraph (3) of this subsection, if its composition and use patterns
are similar to those of a federally registered pesticide.
(3) In no instance may a State issue a registration for a food or
feed use unless there exists a tolerance or exemption under the Federal
Food, Drug, and Cosmetic Act that permits the residues of the pesticides
on the food or feed. If the Administrator determines that a registration
issued by a State is inconsistent with the Federal Food, Drug, and Cosmetic
Act, or the use of, a pesticide under a registration issued by a State
constitutes an imminent hazard, the Administrator may immediately disapprove
the registration.
(4) If the Administrator finds, in accordance with standards set
forth in regulations issued under section 25 of this act, that a
State is not capable of exercising adequate controls to assure that
State registration under this section will be in accord with the
purposes of this Act or has failed to exercise adequate controls,
the Administrator may suspend the authority of the State to register
pesticides until such time as the Administrator is satisfied that the
State can and will exercise adequate controls. Prior to any such
suspension, the Administrator shall advise the State of the
Administrator's intention to suspend and the reasons therefor and
provide the State time to respond.

Sec. 25. [136w] Authority of Administrator.
(a) In General.--
(1) Regulations.--The Administrator is authorized, in accordance with the
procedure described in paragraph (2), to prescribe regulations to
carry out the provisions of this Act. Such regulations shall
take into account the difference in concept and usage between
various classes of pesticides and differences in environmental risk
and the appropriate data for evaluating such risk between
agricultural and nonagricultural pesticides.
(2) Procedure.--
(A) Proposed Regulations.--At least 60 days prior to signing any proposed
regulation for publication in the Federal Register, the Administrator shall
provide the Secretary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator regarding any such regulation
within 30 days after receiving it, the Administrator shall publish in the Federal
Register (with the proposed regulation) the comments of the Secretary and the
response of the Administrator with regard to the Secretary's comments. If the
Secretary does not comment in writing to the Administrator regarding the
regulation within 30 days after receiving it, the Administrator may sign such
regulation for publication in the Federal Register any time after such 30-day
period notwithstanding the foregoing 60-day time requirement.
(B) Final Regulations--At least 30 days prior to signing any regulation in
final form for publication in the Federal Register, the Administrator shall
provide the Secretary of Agriculture with a copy of such regulation. If the
Secretary comments in writing to the Administrator regarding any such final
regulation within 15 days after receiving it, the Administrator shall publish
in the Federal Register (with the final regulation) the comments of the Secretary,
if requested by the Secretary, and the response of the Administrator concerning
the Secretary's comments. If the Secretary does not comment in writing to the
Administrator regarding the regulation within 15 days after receiving it, the
Administrator may sign such regulation for publication in the Federal Register
at any time after such 15-day period notwithstanding the foregoing 30-day time
requirement. In taking any final action under this subsection, the Administrator
shall include among those factors to be taken into account the effect of the
regulation on production and prices of agricultural commodities, retail food
prices, and otherwise on the agricultural economy, and the Administrator shall
publish in the Federal Register an analysis of such effect.
(C) Time Requirements.--The time requirements imposed by subparagraphs (A)
and (B) may be waived or modified to the extent agreed upon by the Administrator
and the Secretary.
(D) Publication in the Federal Register.--The Administrator shall,
simultaneously with any notification to the Secretary of Agriculture under
this paragraph prior to the issuance of any proposed or final regulation,
publish such notification in the Federal Register.
(3) Congressional Committees.--At such time as the Administrator is required under
paragraph (2) of this subsection to provide the Secretary of Agriculture with a copy
of proposed regulations and a copy of the final form of regulations, the Administrator
shall also furnish a copy of such regulations to the Committee on Agriculture of the
House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of
the Senate.
(4) Congressional Review of Regulations.--Simultaneously with the promulgation of
any rule or regulation under this Act, the Administrator shall transmit a copy
thereof to the Secretary of the Senate and the Clerk of the House of Representatives.
The rule or regulation shall not become effective until the passage of 60 calendar
days after the rule or regulation is so transmitted.
(b) Exemption of Pesticides.--The Administrator may exempt from the requirements of
this Act by regulation any pesticide which the Administrator determines either (1)
to be adequately regulated by another Federal agency, or (2) to be of a character
which is unnecessary to be subject to this Act in order to carry out the purposes
of this Act.
(c) Other Authority.--The Administrator, after notice and opportunity for hearing, is
authorized--
(1) to declare a pest any form of plant or animal life (other
than man and other than bacteria, virus, and other micro-organisms
on or in living man or other living animals) which is injurious to
health or the environment;
(2) to determine any pesticide which contains any substance or
substances in quantities highly toxic to man;
(3) to establish standards (which shall be consistent with those
established under the authority of the Poison Prevention Packaging
Act (Public Law 91-601) with respect to the package, container, or
wrapping in which a pesticide or device is enclosed for use or consumption,
in order to protect children and adults from serious injury or illness
resulting from accidental ingestion or contact with pesticides or devices
regulated by this Act as well as to accomplish the other purposes of this
Act;
(4) to specify those classes of devices which shall be subject
to any provision of section 2(q)(1) or section 7 of this Act
upon the Administrator's determination that application of such
provision is necessary to effectuate the purposes of this Act;
(5) to prescribe regulations requiring any pesticide to be
colored or discolored if the Administrator determines that such
requirement is feasible and is necessary for the protection of
health and the environment; and
(6) to determine and establish suitable names to be used in the
ingredient statement.
(d) Scientific Advisory Panel.--The Administrator shall submit to an advisory
panel for comment as to the impact on health and the environment of the action
proposed in notices of intent issued under section 6(b) and of the proposed and
final form of regulations issued under 26(a) within the same time periods as
provided for the comments of the Secretary of Agriculture under such sections.
The time requirements for notices of intent and proposed and final forms of
regulation may not be modified or waived unless in addition to meeting the requirements
of section 6(b) or 25(a), as applicable, the advisory panel has failed to comment
on the proposed action within the prescribed time period or has agreed to the
modification or waiver. The Administrator shall also solicit from the advisory panel
comments, evaluations, and recommendations for operating guidelines to improve the
effectiveness and quality of scientific analyses made by personnel of
the Environmental Protection Agency that lead to decisions by the
Administrator in carrying out the provisions of this Act. The
comments, evaluations, and recommendations of the advisory panel
submitted under this subsection and the response of the Administrator
shall be published in the Federal Register in the same manner as
provided for publication of the comments of the Secretary of Agriculture
under such sections. The chairman of the advisory panel, after
consultation with the Administrator, may create temporary subpanels on
specific projects to assist the full advisory panel in expediting and
preparing its evaluations, comments, and recommendations. The subpanels
may be composed of scientists other than members of the advisory panel,
as deemed necessary for the purpose of evaluating scientific studies
relied upon by the Administrator with respect to proposed action. Such
additional scientists shall be selected by the advisory panel. The panel
referred to in this subsection shall consist of 7 members appointed by
the Administrator from a list of 12 nominees, 6 nominated by the
National Institutes of Health and 6 by the National Science Foundation,
utilizing a system of staggered terms of appointment. Members of the
panel shall be selected on the basis of their professional
qualifications to assess the effects of the impact of pesticides on
health and the environment. To the extent feasible to insure
multidisciplinary representation, the panel membership shall include
representation from the disciplines of toxicology, pathology,
environmental biology, and related sciences. If a vacancy occurs on the
panel due to expiration of a term, resignation, or any other reason,
each replacement shall be selected by the Administrator from a group of
4 nominees, 2 submitted by each of the nominating entities named in this
subsection. The Administrator may extend the term of a panel member
until the new member is appointed to fill the vacancy. If a vacancy
occurs due to resignation, or reason other than expiration of a term,
the Administrator shall appoint a member to serve during the unexpired
term utilizing the nomination process set forth in this subsection.
Should the list of nominees provided under this subsection be
unsatisfactory, the Administrator may request an additional set of
nominees from the nominating entities. The Administrator may require
such information from the nominees to the advisory panel as the
Administrator deems necessary, and the Administrator shall publish in
the Federal Register the name, address, and professional affiliations of
each nominee. Each member of the panel shall receive per diem
compensation at a rate not in excess of that fixed for GS-18 of the
General Schedule as may be determined by the Administrator, except that
any such member who holds another office or position under the Federal
Government the compensation for which exceeds such rate may elect to
receive compensation at the rate provided for such other office or
position in lieu of the compensation provided by this subsection. In
order to assure the objectivity of the advisory panel, the Administrator
shall promulgate regulations regarding conflicts of interest with
respect to the members of the panel. The advisory panel established
under this section shall be permanent. In performing the functions
assigned by this Act, the panel shall consult and coordinate its
activities with the Science Advisory Board established under the
Environmental Research, Development, and Demonstration Authorization Act
of 1978. Whenever the Administrator exercises authority under section
6(c) of this Act to immediately suspend the registration of any
pesticide to prevent an imminent hazard, the Administrator shall promptly
submit to the advisory panel for comment, as to the impact on health and
the environment, the action taken to suspend the registration of such pesticide.
(2) Science Review Board.--There is established a Science Review Board to
consist of 60 scientists who shall be available to the Scientific Advisory Panel
to assist in reviews conducted by the Panel. Members of the Board shall be
selected in the same manner as members of temporary subpanels created under
paragraph (1). Members of the Board shall be compensated in the same manner
as members of the Panel.
(e) Peer Review.--The Administrator shall, by written procedures, provide for
peer review with respect to the design, protocols, and conduct of major
scientific studies conducted under this Act by the Environmental
Protection Agency or by any other Federal agency, any State or political
subdivision thereof, or any institution or individual under grant,
contract, or cooperative agreement from or with the Environmental
Protection Agency. In such procedures, the Administrator shall also
provide for peer review, using the advisory panel established under
subsection (d) of this section or appropriate experts appointed by the
Administrator from a current list of nominees maintained by such panel,
with respect to the results of any such scientific studies relied upon
by the Administrator with respect to actions the Administrator may take
relating to the change in classification, suspension, or cancellation of
a pesticide. Whenever the Administrator determines that circumstances do
not permit the peer review of the results of any such scientific study
prior to the Administrator's exercising authority under section 6(c)
of this Act to immediately suspend the registration of any pesticide
to prevent an imminent hazard, the Administrator shall promptly
thereafter provide for the conduct of peer review as provided in this
sentence. The evaluations and relevant documentation constituting the
peer review that relate to the proposed scientific studies and the
results of the completed scientific studies shall be included in the
submission for comment forwarded by the Administrator to the advisory
panel as provided in subsection (d). As used in this subsection, the
term "peer review" shall mean an independent evaluation by scientific
experts, either within or outside the Environmental Protection Agency,
in the appropriate disciplines.

Sec. 26. [136w-1] State Primary Enforcement Responsibility.
(a) In General.--For the purposes of this Act, a State shall have primary
enforcement responsibility for pesticide use violations during any
period for which the Administrator determines that such State--
(1) has adopted adequate pesticide use laws and regulations,
except that the Administrator may not require a State to have
pesticide use laws that are more stringent than this Act;
(2) has adopted and is implementing adequate procedures for the
enforcement of such State laws and regulations; and
(3) will keep such records and make such reports showing
compliance with paragraphs (1) and (2) of this subsection as the
Administrator may require by regulation.
(b) Special Rules.--Notwithstanding the provisions of subsection (a) of
this section, any State that enters into a cooperative agreement with the
Administrator under section 23 of this Act for the enforcement of
pesticide use restrictions shall have the primary enforcement
responsibility for pesticide use violations. Any State that has a plan
approved by the Administrator in accordance with the requirements of
section 11 of this Act that the Administrator determines meets the
criteria set out in subsection (a) of this section shall have the
primary enforcement responsibility for pesticide use violations. The
Administrator shall make such determinations with respect to State plans
under section 11 of this Act in effect on the date of enactment of the
Federal Pesticide Act of 1978 not later than six months after that date.
(c) Administrator.--The Administrator shall have primary enforcement responsibility
for those States that do not have primary enforcement responsibility under
this Act. Notwithstanding the provisions of section 2(e)(1) of
this Act, during any period when the Administrator has such
enforcement responsibility, section 8(b) of this Act shall apply to
the books and records of commercial applicators and to any applicator
who holds or applies pesticides, or uses dilutions of pesticides, only
to provide a service of controlling pests without delivering any
unapplied pesticide to any person so served, and section 9(a) of this
Act shall apply to the establishment or other place where pesticides
or devices are held for application by such persons with respect to
pesticides or devices held for such application.

Sec. 27. [136w-2] Failure by the State to Assure Enforcement of State Pesticide
Use Regulations
(a) Referral.--Upon receipt of any complaint or other information alleging or
indicating a significant violation of the pesticide use provisions of
this Act, the Administrator shall refer the matter to the
appropriate State officials for their investigation of the matter
consistent with the requirements of this Act. If, within thirty
days, the State has not commenced appropriate enforcement action, the
Administrator may act upon the complaint or information to the extent
authorized under this Act.
(b) Notice.--Whenever the Administrator determines that a State having primary
enforcement responsibility for pesticide use violations is not carrying
out (or cannot carry out due to the lack of adequate legal authority)
such responsibility, the Administrator shall notify the State. Such
notice shall specify those aspects of the administration of the State
program that are determined to be inadequate. The State shall have
ninety days after receipt of the notice to correct any deficiencies. If
after that time the Administrator determines that the State program
remains inadequate, the Administrator may rescind, in whole or in part,
the State's primary enforcement responsibility for pesticide use
violations.
(c) Construction.--Neither section 26 of this Act nor this section shall limit
the authority of the Administrator to enforce this Act, where the
Administrator determines that emergency conditions exist that require
immediate action on the part of the Administrator and the State
authority is unwilling or unable adequately to respond to the emergency.

Sec. 28. [136w-3] Identification of Pests; Cooperation with Department of
Agriculture's Program
(a) In General.--The Administrator, in coordination with the Secretary of
Agriculture, shall identify those pests that must be brought under
control. The Administrator shall also coordinate and cooperate with the
Secretary of Agriculture's research and implementation programs to
develop and improve the safe use and effectiveness of chemical,
biological, and alternative methods to combat and control pests that
reduce the quality and economical production and distribution of
agricultural products to domestic and foreign consumers.
(b) Pest Control Availability.--
(1) In General.--The Administrator, in cooperation with the Secretary of
Agriculture, shall identify--
(A) available methods of pest control by crop or animal;
(B) minor pest control problems, both in minor crops and
minor or localized problems in major crops; and
(C) factors limiting the availability of specific pest
control methods, such as resistance to control methods and
regulatory actions limiting the availability of control methods.
(2) Report.--The Secretary of Agriculture shall, not later than 180 days
after the date of enactment of this section and annually thereafter, prepare
a report and send the report to the Administrator. The report shall--
(A) contain the information described in paragraph (1) and
the information required by section 1651 of the Food, Agriculture,
Conservation, and Trade Act of 1990;
(B) identify the crucial pest control needs where a shortage
of control methods is indicated by the information described in
paragraph (1); and
(C) describe in detail research and extension efforts
designed to address the needs identified in subparagraph (B).
(c) Integrated Pest Management.--The Administrator, in cooperation with
the Secretary of Agriculture, shall develop approaches to the control of
pests based on integrated pest management that respond to the needs of
producers, with a special emphasis on minor pests.
(d) Public Health Pests.--The Administrator, in coordination with the
Secretary of Agriculture and the Secretary of Health and Human Services,
shall identify pests of significant public health importance and, in
coordination with the Public Health Service, develop and implement
programs to improve and facilitate the safe and necessary use of chemical,
biological, and other methods to combat and control such pests of public
health importance.

Sec. 29. [136w-4] Annual Report.
The Administrator shall submit an annual report to Congress before
February 16 of each year and the first report shall be due February 15,
1979. The report shall include the total number of applications for
conditional registration under sections 3(c)(7)(B) and 3(c)(7)(C)
of this Act that were filed during the immediately preceding fiscal
year, and, with respect to those applications approved, the
Administrator shall report the Administrator's findings in each case,
the conditions imposed and any modification of such conditions in each
case, and the quantities produced of such pesticides.

Sec 30. [136w-5] Minimum Requirements for Training of Maintenance
Applicators and Service Technicians.
Each State may establish minimum requirements for training of maintenance
applicators and service technicians. Such training may include instruction
in the safe and effective handling and use of pesticides in accordance with
the Environmental Protection Agency approved labeling, and instruction in
integrated pest management techniques. The authority of the Administrator
with respect to minimum requirements for training of maintenance applicators
and service technicians shall be limited to ensuring that each State understands
the provisions of this section.

Section 31. [136w-6] Environmental Protection Agency Minor Use Programs.
(a) The Administrator shall assure coordination of minor use issues through the
establishment of a minor use program within the Office of Pesticide Programs. Such
office shall be responsible for coordinating the development of minor use programs
and policies and consulting with growers regarding minor use issues and registrations
and amendments which are submitted to the Environmental Protection Agency.
(b) The Office of Pesticide Programs shall prepare a public report concerning the
progress made on the registration of minor uses, including implementation of the
exclusive use as an incentive for registering new minor uses, within 3 years of
the passage of the Food Quality Protection Act of 1996.

Section 32 [136w-7] Department of Agriculture Minor Use Program.
(a) In General.--The Secretary of Agriculture (hereinafter in this section
referred to as the "Secretary") shall assure the coordination of the
responsibilities of the Department of Agriculture related to minor uses
of pesticides, including--
(1) carrying out the Inter-Regional Project Number 4 (IR-4) as described
by section 2 of Public Law 89-106 (7 U.S.C. 450i(e)) and the national pesticide
resistance monitoring programs established under section 1651 of the Food,
Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 5882);
(2) supporting integrated pest management research;
(3) consulting with growers to develop data for minor uses; and
(4) providing assistance with minor use registrations, tolerances, and
reregistrations with the Environmental Protection Agency.
(b)(1) Minor Use Pesticide Data.--
(A) Grant Authority.--The Secretary, in consultation with the Administrator,
shall establish a program to make grants for the development of data to support
minor use pesticide registrations and reregistrations. The amount of any such
grant shall not exceed 1/2 of the cost of the project for which the grant is made.
(B) Applicants.--Any person who wants to develop data to support minor use
pesticide registrations and reregistrations may apply for a grant under
subparagraph (A). Priority shall be given to an applicant for such grant who
does not directly receive funds from the sale of pesticides registered for
minor uses.
(C) Data Ownership.--Any data that is developed under a grant under
subparagraph (A) shall be jointly owned by the Department of Agriculture and
the person who received the grant. Such a person shall enter into an agreement
with the Secretary under which such person shall share any fee paid to such
person under section 3(c)(1)(F).
(2) Minor Use Pesticide Data Revolving Fund.--
(A)Establishment.--There is established in the Treasury of the United States
a revolving fund to be known as the Minor Use Pesticide Data Revolving Fund. The
Fund shall be available without fiscal year limitation to carry out the
authorized purposes of this subsection.
(B) Contents of the Fund.--There shall be deposited in the Fund--
(i) such amounts as may be appropriated to support the purposes of this
this subsection; and
(ii) fees collected by the Secretary for any data developed under a grant
under paragraph (1)(A).
(C) Authorization of Appropriations.--There are authorized to be appropriated
for each fiscal year to carry out the purposes of this subsection $10,000,000 to
remain available until expended.

Sec. 33. [136x] Severability.
If any provision of this Act or the application thereof to
any person or circumstance is held invalid, the invalidity shall not
affect other provisions or applications of this Act which can be
given effect without regard to the invalid provision or application, and
to this end the provisions of this Act are severable.

Sec. 34. [136y] Authorization of Appropriations.
There is authorized to be appropriated to carry out this Act (other than section 23(a))--
(1) $83,000,000 for fiscal year 1989, of which not more than
$13,735,500 shall be available for research under this Act;
(2) $95,000,000 for fiscal year 1990, of which not more than
$14,343,600 shall be available for research under this Act;
and
(3) $95,000,000 for fiscal year 1991, of which not more than
$14,978,200 shall be available for research under this Act.